Articles Posted in Advances in Patient Safety

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.

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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.

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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.

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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.

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A national pharmacy chain has partnered with a medical school and a pharmacy school to open a store that will explore a new model for patient care. The “Walgreens at UCSF” store, located on the University of California, San Francisco campus, is reportedly designed to enable extensive communication between pharmacists and patients. Substantial numbers of people in the U.S. take prescription and over-the-counter medications on a daily basis, and medication errors are a significant cause of injuries and deaths. Various hospitals and other medical facilities are trying out different models of care in an effort to reduce the number of medication errors, and the severity of the injuries they may cause, as much as possible.

The central idea behind Walgreens at UCSF, like many other experimental programs, is the importance of communication between patients, physicians, and pharmacists. Few pharmacies are designed with one-on-one pharmaceutical counseling in mind, and pharmacists tend to remain in the back of the store. The store includes a 1,200-square-foot area with numerous private consultation areas, which pharmacists can use to meet with patients. UCSF describes a concierge desk where patients can check prescriptions and set up pharmacist consultations. Pharmacists employed by both the university and Walgreens will work side-by-side. Rather than simply dispensing medications, pharmacists would work with patients to help them understand how to take medications properly, and provide them with a better overall picture of their health.

According to UCSF, citing the Centers for Disease Control and Prevention (CDC), eighty-two percent of people in the U.S. take medication on a daily basis. Twenty-nine percent take at least five medications per day. Medication errors can occur at any stage of the treatment process, with doctors making a prescription error, pharmacies dispensing the wrong medication or wrong dosage, and patients not following the directions for their medication. UCSF cites statistics from the National Consumers League stating that three-fourths of Americans do not always follow medication instructions, while about one-third do not always take prescribed medications at all. Medication errors cause as many as 1.5 million injuries, 700,000 emergency room visits, and 7,000 deaths every year, at a cost of around $3.5 billion.

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A new study, conducted in Irish hospitals and published in a British journal, reviewed the effectiveness of a “collaborative” model of managing hospital patients’ medications. The model, known as the Collaborative Pharmaceutical Care in Tallaght Hospital (PACT), involves close involvement of clinical pharmacists in all stages of patient care during their stay in the hospital. The study, which was uncontrolled, found that PACT resulted in a reduction in the rate of medication errors by more than three-fourths.

The study was published in the online edition of the British Medical Journal Quality & Safety on February 6, 2014. The researchers compared the benefits of PACT to “standard ward-based clinical pharmacy,” with a focus on adult hospital patients receiving acute care, who were prescribed at least three medications in the hospital, and who left the hospital alive. The study included 112 patients receiving care based on PACT, and 121 patients receiving standard care. They measured the rates of medication errors and of potentially severe errors per patient.

According to the description provided in the study, the primary goal of PACT is to reduce the rate of medication errors that commonly occur when a patient is transferred between doctors or departments within a hospital, or transferred from one facility or organization to another, by improving the process of “medication reconciliation” (MedRec). This involves comparing a patient’s current medication orders to the medications a patient has been taking in order to prevent omission of a necessary drug, inclusion of an unnecessary or dangerous drug, or incorrect dosages.

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A hospital in Houston, Texas has adopted a “narrative-based approach” of communicating the details of medication errors to hospital staff (login required). A medication safety consultant employed by the hospital found that the prior approach, which relied on unit managers to pass along information to their teams, was not leading to greater institutional knowledge about how to avoid medication errors. The new approach involves the production of short videos detailing the issues that led to a specific medication error. The success of the program is difficult to measure, as it is based solely on self-reporting by hospital leaders who seemed to perceive a substantial reduction in medication errors during the eight-month pilot program. The program bears some similarities to how many attorneys approach claims for pharmacy and medication errors, as a narrative story told to the judge and the jury.

MD Anderson Cancer Center ran a pilot program from October 2012 to June 2013. Every month, a team consisting of a nurse, a pharmacist, and a patient safety specialist would review recent medication errors to identify important concerns. They would decide on three events or issues, and another multidisciplinary team would pick one to use in a video. The hospital’s communications department would handle the actual production, including writing a script, shooting and editing the video, and formatting it into a PowerPoint presentation.

Once the hospital administration approved the final video, it would be uploaded to the hospital’s intranet. The hospital’s various department heads and team leaders would be notified of the new video. The leaders would then be responsible for showing the video to their teams. The hospital produced one video a month for eight months. Hospital leaders reportedly accessed the videos more than 3,500 times during that period, and eighty-three percent of them showed the videos during staff meetings. A majority of leaders said in survey responses that the videos were a “very” or “extremely” successful means of communication. The hospital permanently adopted the program, and has expanded it to share other information besides medication errors.

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Following the widespread contamination problems at several compounding facilities, hospitals and pharmacies have begun to reevaluate the potential options for improving sterility and quality of compounded IV fluids and related products.

One potential option is the use of robots in lieu of pharmacists or technicians. One such robot is called RIVA, a fully automated IV compounding robot. The vice president of marketing at the company which sells RIVA stated that hospitals were already expressing an interest in their product prior to the contamination issues, but that interest had piqued following the incidents.

The primary draw of such automated systems is the fact that it minimizes the potential for human error, given the fact that there is very little human manipulation involved in the process. In essence, an individual inputs the stock drug vials, the bags to be filled, empty syringes, and whatever other components may be required, sets the parameters for production, presses the start button, and then takes the finished and labeled mixed bags or syringes from the output chutes. Thus, in addition to lowering the chance for human error in actually compounding the drugs, there is also a considerably lower chance of contamination, since the robots contain an aseptic environment, and the only touching happens before and after the mixing has occurred.

Additionally, the RIVA machine in particular has multiple accuracy checks in place. These include:

  • weighing of drug vials before and after use
  • weighing of syringes prior to and following filling
  • comparison of photos of drug labels with file photos, and
  • bar code scanning

Preparations failing any of these tests are automatically rejected by the machine. Additionally, pulsed ultraviolet light flashes at vials throughout various sanitation points. Throughout periodic testing for contamination following installation of a RIVA unit has failed to produce a single positive culture thus far.

The unit operates 18 to 22 hours daily, during which time it can fill approximately 400 to 500 syringes. The robot can be programmed to produce batches of individualized patient specific doses, or larger batches of the same drug and dose. According to IHS, the company who sells RIVA, preparing 350 syringes for the machine requires approximately three hours of a technician’s time.

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Serious complications and injuries can result from discrepancies between the medications patients take at home, the medications they receive in the hospital, and the medications they take home with them. To prevent such medication errors, a recent study out of Johns Hopkins recommends that hospitals train teams of nurses and pharmacists to reconcile patients’ medication lists. Such teams could better ensure that patients receive consistent medications and dosages, at a lower cost to both the hospital and the patient, thus improving overall health and safety for hospital patients.

The Journal of Hospital Medicine published the study, entitled “Nurse-pharmacist collaboration on medication reconciliation prevents potential harm,” in its May/June 2012 issue. The purpose of the study was to test how “medication reconciliation” could help prevent “adverse drug effects” (ADEs). The study involved over five hundred patients at a “1000 bed urban, tertiary care hospital” from January 2008 through March 2009. Nurses would conduct an interview with patients to obtain a home medication list (HML), outlining all medications regularly taken by the patients. Patients often forgot or otherwise omitted some medications during this process, or were unable to remember the name or dosage of a drug. Some patients could only provide a description of the drug’s appearance, and many were not certain what condition a particular drug treated. Discrepancies between the medications a patient was actually taking and those they received during treatment and upon discharge occurred in forty percent of hospital visits, according to the researchers.

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