Advances in Patient Safety

Pharmacy Error Rates May Be Artificially Low Due to a Lack of Mandatory Reporting Requirements

June 29, 2017 | Lebowitz & Mzhen

Chances are anyone who has followed the news over the past few months has noticed at least one serious pharmacy error occurring at either a hospital or a retail pharmacy. Indeed, the Food and Drug Administration estimates that there is on average one death per day in addition to approximately 1.3 million people harmed per year by pharmacy errors. However, these statistics are only estimates because the real number of errors cannot be determined, due to discretionary reporting requirements.

As the law stands now, pharmacies are not required to report most of the errors that their pharmacists make. While some errors come to the public’s attention due to widespread press coverage or because a pharmacy error victim files a personal injury lawsuit, many errors go unreported. Thus, the true number of pharmacy errors is unknown.

According to a recent article, our neighbors to the north in Ontario, Canada have begun to implement mandatory reporting requirements. Evidently, the change in the law was spurred on by the death of an eight-year-old boy last year. The report indicates that the boy suffered from sleeping problems and was prescribed tryptophan by his pediatrician. The boy’s mother called in the prescription and went to pick up what she thought was tryptophan, but what she was given was actually baclofen, a powerful muscle relaxer. After the boy’s death, the coroner reported that “logic would dictate that baclofen was substituted for tryptophan at the compounding pharmacy in error.”

The Lack of Mandatory Reporting Requirements in U.S. Pharmacies

April 3, 2017 | Lebowitz & Mzhen

In most professions, when someone makes a serious error that affects the health or safety of another person, it becomes public knowledge. Indeed, we often read in the news about reports of doctors, police officers, and politicians who make questionable judgment calls. The fact that these lapses in judgment become public knowledge allows for the public to better understand the errors and encourages brainstorming about how to reduce those errors in the future through better policy-making and enforcement.

Pharmacists, however, do not face mandatory reporting requirements in much of the country. In fact, in most states, pharmacists are given discretion about when to report most errors. Interestingly, Maryland is ahead of the curve in requiring that certain adverse patient-related events, including medication errors, be reported within five days by medical professionals, including pharmacists.

The Seriousness of Pharmacy Errors

The Food and Drug Administration estimates that medication errors cause more than one death a day and injure over 1.3 million people annually. While not every prescription error will result in a serious injury or death, it is important to realize that the effects of a pharmacy error may not be immediately apparent. In some cases, medical experts are required to establish which, if any, consequences a patient who has been provided the wrong medication may face in the future.

Despite the High Prevalence of Pharmacy Errors, Pharmacists Resist Lawmakers’ Attempt to Impose Stricter Guidelines

March 13, 2017 | Lebowitz & Mzhen

By any account, pharmacists do not have an easy job. They often fill hundreds of prescriptions per shift, meet with dozens of clients for consultations, and must also maintain their internal inventory systems throughout the day. Pharmacists are human, and with these burdens being placed upon them day after day, it is no surprise that the rate of pharmacy errors is as high as it is.

According to one news report that discussed a study it conducted of Chicago-area pharmacies, 52% of all pharmacies surveyed failed to warn patients about a dangerous drug interaction. This study didn’t take into account other types of pharmacy errors, such as providing the patient with the wrong dose of medication or the wrong type of medication altogether. The news agency looked mostly at both independent and national-chain pharmacies, discovering that CVS had a failure rate of 62%, Walgreen’s had a failure rate of 30%, and independent pharmacies had a failure rate of 72%.

Due to the concerns surrounding pharmacy errors, lawmakers have recently started to try to implement stricter guidelines for pharmacists. The proposed changes would limit a pharmacist’s workday to 8 hours, require pharmacists take two 15 minute breaks and an hour lunch, and limit the number of prescriptions filled per hour and per shift. Despite the undeniably high error rates, some pharmacies and pharmacists have opposed the newly proposed laws.

Some Pharmacy Errors Caused by Small Print on Medication Bottles and Other Medical Literature

November 29, 2016 | Lebowitz & Mzhen

A recently published medical industry report attempts to point out the surprising threat that American patients face every day in doctor’s offices and hospitals due to the small print that is used on many prescription forms, medication bottles, and medical review materials. The report, which was supplied to the publisher by a company seeking to profit from the present-day problem, notes that a survey of health care professionals performed in 2014-2015 found that almost 90% of doctors, nurses, and other health care professionals reported difficulty reading the small print found on drug labels and that over 35% were aware of a close call or actual prescription error that occurred because of the small print on some medical materials.

Doctors Who Don’t Need Reading Glasses or Assistance From a Colleague with Adequate Vision May Make Mistakes and then Blame the Small Print

The report contains startling information that millions of patients may be placed at risk every day because doctors and nurses are unable to read medication bottles correctly, and some of these professionals apparently do not take the initiative to ensure that their eyes are functioning well enough to protect their patients from a pharmacy or medical error stemming from a piece of medical literature that is read incorrectly. The article seems to place the blame for these errors and any injuries, illnesses, or deaths they cause upon the small print that is used on medication bottles. However, the bottom line is that medical professionals are responsible for reading what is on medication bottles and other literature before they give a potentially dangerous medication to a patient.

If a medical professional is unable to read a piece of text and does not seek assistance by consulting a colleague, putting on some glasses, using an app on their smartphone, or using a piece of magnification equipment to ensure that they understand what they are doing, they should be held responsible for any injuries that are caused by their mistake.

Hospital Implements New Safety Procedures to Reduce Pharmacy Errors

September 12, 2016 | Lebowitz & Mzhen

In order to reduce pharmacy errors, a hospital in Japan has adopted quality control procedures developed and used by Toyota, according to a recent article. The new procedures are intended to improve workflow among the hospital’s 30 pharmacists, who work in staggered shifts among racks and racks of prescription medications.

Prior to adopting Toyota’s safety measures, the hospital was known to have committed more than 10 pharmacy errors per month. After studying and implementing the new procedures, the hospital has reduced pharmacy errors by more than 50 percent.

Pharmacy errors are a worldwide problem, including in the United States. Common hospital pharmacy errors include giving patients the wrong dose of a medication, giving them the wrong medication altogether, or unintentionally giving them another patient’s medication.

People Suffering from Complex Diseases Experience More Frequent Medication Errors

May 27, 2016 | Lebowitz & Mzhen

Almost everyone has been to the pharmacy to fill a prescription at some point in their life. In fact, many people routinely visit the pharmacy each month to get their regular prescriptions filled for maintenance medications. Some of these frequent pharmacy customers have many different prescriptions of which the pharmacist must keep track. And in the case of some HIV patients, the varying doses of the prescribed medication adds yet another element for pharmacy staff to handle.

No matter how complex a patient’s prescription order may be, pharmacists are required to take their time with each order, ensuring that it is properly filled and labeled. In the case of some patients with complex prescription orders, like those diagnosed with HIV, this may mean a significant amount of work for the pharmacist, including fielding constant updates from a patient’s care providers about the patient’s status and current prescription requirements. With this increased workload, unfortunately, comes an increased chance that an error will be made.

HIV Patients Are Especially at Risk for Medication Errors

According to a recent article by an industry news source, a study may have come up with a way that can decrease the likelihood of medication errors in HIV patients. As with other illnesses, the transitional time between care providers is the most dangerous time for HIV patients. The premise of the study was simple: increase the amount of face-to-face contact the pharmacist has with the patient. Specifically, the pharmacist would be present at the patient’s admission to the hospital as well as each day for some defined period.

As Specialty Mail-Order Pharmacies Proliferate, Accuracy Counts

July 22, 2015 | Lebowitz & Mzhen

Over the last decade or so, the number of specialty pharmacies in the industry has greatly increased. According to one industry news report, this is due in part to the fact that drug manufacturers prefer to rely on a specialized pharmacy to assist patients with the administration and use of their drug than to rely on regular retail pharmacies. However, as the article notes, as more and more patients rely on these specialty mail-order pharmacies, the accuracy of these pharmacies becomes critical to patient health.

Most often, specialty pharmacies deal with very expensive medication. In many cases, this medication is provided to the patient in fairly small amounts in order to prevent what pharmacists call stockpiling, or refilling a prescription a few days early and saving the remaining doses. However, while stockpiling may be seen as a negative from the pharmacy’s and drug manufacturer’s point of view, it means that the accuracy of these pharmacies must be spot on, or else patients may miss a dose.

If a pharmacy only sends out enough medication to last a certain amount of time, and there is an error in the shipment, that may mean that a patient does not receive their required medication for several days. In some cases, this can result in serious health consequences. In fact, the article notes that it is not uncommon for a pharmacy to make an error in the quantity of medication that is sent to a patient, leaving them with less than the required amount for a given time period. Most often, a pharmacy will act quickly to remedy this error, but that doesn’t mean that the consequences can always be avoided.

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.

Some Pharmacists Resist the Common-Sense Idea of Translating Prescription Instructions

August 13, 2014 | Lebowitz & Mzhen

In areas of the country where there is a large minority of non-English speakers, some pharmacies have been pressured to translate the prescription instructions into the predominant language in the area. For example, one article explains that some California pharmacies are being pressured to translate their instructions into Chinese and Vietnamese in order to cater to the large Chinese and Vietnamese communities in that state.

Indeed, this makes intuitive sense. How can someone who does not speak English effectively translate and understand a prescription label? By translating the instructions for the patients, pharmacists help ensure that the patients are taking the medication as prescribed by the doctor. If patients don’t obey the prescriber’s instructions, there could be drastic consequences, such as serious injury or even death.

Pharmacists Resist the Idea

New York has recently passed a law that requires pharmacists to provide translated labels, and there is currently the same discussion going on in California as well. However, some pharmacists are resisting the idea. Those against the idea offer up two reasons. First, they claim that the translated labels would require larger bottles, and people generally prefer smaller bottles of medication. The risk is that if the bottle is too large, they argue, the patient is going to take the pills out of the bottle and put them into something more convenient, without the instructions.

FDA Approves Prescription-Based Antidote for Overdose of Heroin, Other Opioids

April 15, 2014 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) approved a “hand-held auto-injector” device for use with known or suspected opioid overdoses. Abuse of opioids, a group of drugs that includes many prescription painkillers, is becoming a serious problem in the U.S., and the FDA claims that opioid overdose has surpassed automobile accidents as the nation’s leading cause of injury deaths. The device, marketed under the brand name Evzio, delivers an injection of naloxone hydrochloride to counter or reverse the effects of opioid overdose. The FDA has stated that it hopes the availability of the device with a prescription will help prevent overdose deaths in emergency situations.

Opioid analgesics are a family of opiate-based drugs commonly used in prescription painkillers. They are derived from the same source as heroin and several other illegal narcotics. Common opioids include codeine, hydrocodone, morphine, and oxycodone. Opioids can be very addictive, so they are tightly controlled by the government. According to the Centers for Disease Control and Prevention (CDC), 16,651 people died of drug overdoses involving opioids in 2010, the most recent year for which statistics are available. This number accounts for about seventy-five percent of all drug overdose deaths that year. Many overdoses involve legally-obtained prescription painkillers. The total number presumably includes intentional and accidental overdoses, as well as dosage errors by a physician or pharmacist.

Evzio, as approved by the FDA, is a handheld device that injects naloxone hydrochloride, an “opioid antagonist” that is a common treatment for opioid overdose. Emergency responders often carry naloxone-containing products for use with suspected overdose victims. Since Evzio is only available with a prescription, it must be obtained in advance of any emergency situation. It is recommended for family members and caregivers of people using opioid painkillers in case of overdose. The device provides verbal instructions for use once it is turned on. A single dose of naloxone, according to the FDA, does not last as long as a typical opioid, so it cautions that the device is not a substitute for medical attention. What the device can do is delay further injury or death due to an overdose until medical attention is available.