Instructor: Vanessa Mrazek, MBA, CPhT
Introduction Medication Errors According to the Institute of Safe Medication Practices (ISMP), a medication error is defined as any preventable event that may cause or lead to inappropriate medication use or harm while the medication is in control of the health care professional, patient or consumer. Such events can be related to professional practice, health care products, procedures and pharmacy systems including: prescribing, communication, labeling, packaging, nomenclature, compounding, dispensing, distribution, administration, education, monitoring and use. The Institute of Medicine (IOM) estimates that 1.5 million people are sickened, injured or die annually as a result of medication errors. Pharmacists report that high workload and unexpected consequences from technologies that assist pharmacists in filling prescriptions and providing alerts about possible drug interactions increase the potential for medication errors, according to a 2006 study published in Medical Care. When a medication error occurs, it generally is the result of a deficiency in one of two areas: knowledge or performance. There are a few pharmacy systems that have been designed and put in place to help reduce the number of errors; however, some errors that will continue to be made. According to a study done by the Temple University School of Pharmacy in 2008, three billion prescriptions are dispensed annually in the United States. A 99.9% dispensing accuracy still results in 3 million errors. When you look at one percent of three million, that means 30,000 patients are harmed by medication errors. In hospitals, 3.75 billion drugs are administered annually; here, a 99.9% dispensing accuracy still results in 3.75 million errors. When you look at one percent of 3.75 million, that means 37,500 patients are harmed by medication errors. This same Temple University study broke the information down even further: In Community Pharmacies: 18% of patients in the community experience an adverse drug event (ADE), greater than 50% of the office visits made because of an ADE are preventable, and up to 28% of emergency department visits are found to be because of preventable medication mismanagement. It was also found that five to 10% of all hospital admissions are from an ADE that was preventable and about one third of drug-induced hospital admissions involve patient noncompliance issues. In Hospital Settings: 10% to 30% of hospitalized patients have an ADE occur during their stay, with one to three percent of these being significant. Each ADE costs the hospital about $5,000 per patient and 30 to 50% are considered to be preventable. In Long-Term Care Settings: There are an average of 1.89 ADEs per 100 residents and more than 50% are considered to be preventable. Polypharmacy is found to be a problem in long-term care with the average number of medications a patient takes ranging from five to eight per day. The percentage of ADEs when patients are taking one to three drugs is six percent. The percentage of ADEs when patients are taking more than drugs is 52% Prescribing errors that are reported the most include inappropriate dose, wrong medication for the condition and incomplete medication name. Dispensing errors include mechanical errors and judgment errors. Mechanical errors include wrong strength, wrong medication, wrong quantity, wrong directions on the label and the wrong patient. All of these mechanical errors fall under the responsibilities of a pharmacy technician and are the most commonly reported medication errors of all of the classifications. Judgment errors include drug utilization reviews and counseling of patients. Administration errors include the wrong route and wrong drug form. The most common medication errors include: Illegible handwriting Look alike Sound alike Ambiguous orders Medication selection Sterile admixtures Handwritten scripts lead to medication errors through illegible, ambiguous or incomplete orders. Several solutions that have been put into place include pre-printed orders, typed orders, dictated orders and direct order entry into the computer by the physician, known as computerized physician order entry (CPOE). As a technician, it is important to always keep the label with the prescription so that the pharmacist can check the interpretation of the handwriting. But even this is not a failsafe. It is still important for technicians to be properly trained on what a correct prescription looks like and all of the components it should have before they take the prescription from the patient to be filled. Even though hospitals, long-term care, and even some doctors' offices have begun using these pre-printed and computerized prescriptions they are only as good as their user. There is still the option for doctors to input a non-existent medication and it is still possible for them to use a sig short code that does not apply. The most common mistake found in prescriptions is when a medication with a route of administration that is not oral, ends up with the directions take by mouth because the short codes used for frequency of administration (time) include the route of administration, in this case, by mouth (PO) is mistaken for QD (daily) . From January 2000 to March 2004, close to 32,000 reports were submitted to MedMARx reporting system for look-alike errors. It is important for pharmacy technicians to be trained properly on the awareness of look-alike medications and how to recognize the chance for error immediately. ISMP recently updated their confused drug name list and an alert was sent out to pharmacies last month warning about new medications added to the list. Drug orders communicated verbally are often misheard, misunderstood, misinterpreted or transcribed incorrectly. Proper training in what strength and drug form are available as well as diagnosis can help with deciphering sound alike drugs. Confusing drug names or look alike - sound alike (LASA) drugs are among the most common reasons for medication errors worldwide. In 2007, the Joint Commission and the World Health Organization made this problem the subject of their first public safety solutions report. LASA errors can lead to both morbidity and mortality. A study published in the American Journal of Health System Pharmacy assessed deaths related to medication errors. Of the 5,366 medication errors they reviewed, 16% resulted from the wrong drug and 10% from the wrong administration route - all 26% of which were linked to LASA drug names. In February 2008, the USP released its annual MedMARx report showing that among 26,000 medication error records between 2003 and 2006, 384 of them were due confusing LASA drugs with 64.4% originated at the pharmacy; pharmacy technicians committed errors 39% of the time. LASA medications highlighted in this report included Mellaril /Elavil, Paxil/Taxol, Prilosec/Prozac, and Celebrex/Celexa. An April 2008 issue of CAPSlink showed that between 2003 and 2006, more than 3,170 medication errors were due to LASA medications. Several efforts can be made to prevent LASA medication errors including patient education. During office visits, physicians should have a discussion with their patients detailing their medication and what it is being used for specifically. The physician should also try and get in the habit of writing the diagnosis for each medication on the prescription to avoid name mix-ups. In some of these cases, serious consequences have occurred. It can not be stressed enough that being trained to recognize a possible error while knowing a drug's purpose and a patient's diagnosis can help prevent these errors. The most commonly reported drug class with ambiguous orders is analgesics. The Journal of Pain has reported that the frequency of medication errors involving analgesics is around three for every 1,000 prescriptions. Researchers at Albany Medical Center in New York conducted a similar study and found the similar results: 2.87 medication errors for every 1,000 prescriptions written. It is important for doctors and pharmacies to work together to reduce the number of medication errors, especially when errors involving one drug class are so pronounced. When preparing fluids for injectable administration, the potential for error is increased for multiple reasons, the most serious and common of which are that the fluids are clear, colorless water-based medications. This causes them to all look alike regardless of the drug or concentration. The chance of a dose miscalculation or measurement is higher in these situations. One way to avoid calculation and measurement errors is to avoid the process all together and purchase as many premixed solutions as possible. Another way is to provide all physicians that you service with a standardized dosing chart that enables each order for that medication to be made exactly the same each and every time. Having automated equipment to help with admixtures also helps to reduce the number of medication errors. Overworked pharmacists rely increasingly on pharmacy technicians to help process a growing volume of prescriptions and perform administrative work, but the national debate over how technicians should be regulated and certified has yet to be resolved. Data through March 2009 from the National Association of Boards of Pharmacy (NABP) reveal that of the 50 states and the District of Columbia, Guam and Puerto Rico, 42 regulate pharmacy technicians. Eight states do not, including Colorado, Delaware, Georgia, Hawaii, Michigan, New York, Pennsylvania and Wisconsin. Florida, Guam and Ohio only recently adopted regulations. More than 85% of Americans mistakenly believe pharmacy technicians are uniformly trained and certified. IOM released a report in 2006 entitled Preventing Medication Errors which indicated that medication errors are among the most common medical errors, harming an average of 1.5 million people per year. The report also showed 400,000 preventable drug-related injuries occur each year in hospitals, 800,000 in long-term care, and 530,000 in outpatient clinics serving Medicare recipients. Protecting customers and patients from unnecessary and inappropriate medication errors has become an important issue for pharmacists and technicians alike, including those working in community, institutional and other settings. Technicians play a major role in causing medication errors, identifying errors and how to prevent them. A recent large scale study of both new prescriptions and refills show that an average of 1.7% error rate. This translates to four errors for every 250 medications filled or 51.5 million for every three billion prescriptions filled each year. A majority of these errors do not harm the patient and it is believed that the error rate of over-the-counter and non-prescription medications that are not under the control of a physician or pharmacist is higher. Pediatric Errors Errors associated with medications are believed to be the most common type of medical error and are a significant cause of preventable ADEs. Medication errors with the potential to cause harm are eight times more likely to occur in neonatal intensive care units (NICUs). System errors, or those caused by having a wide variety of concentrations and dosage forms available to choose from, in both hospital stock and the available stock by the manufacturer, are the main cause of errors in the NICU. Common errors have been found to be due to weaknesses in the system including medication storage, labeling, knowledge of concentrations and administration routes available and documentation. Children are at higher risk for medication errors and resulting harm than adults for several reasons. Medications that are often available are manufactured for the average adult and therefore have to be compounded to meet the needs of a child. Children are smaller and do not have organs functioning at the same level as adults,; their renal and hepatic functions are not able to tolerate the average adult dose. As important as it is to ensure that calculations have been done out correctly and the medication has been compounded correctly, it is equally important to ensure that the amount to be administered is relevant to the child's age. A three-month-old child is less likely to receive the entire amount of a 10 mL dose of a medication as they are more prone to dribbling, drooling and pushing things back out with their tongue. Medication errors affect the pediatric population regardless of the type of pharmacy setting, be it outpatient, inpatient, emergency room or retail. Children are at a higher risk of potential harm due to their physiology, limited communication skills and treatment by those not specializing in pediatrics. Studies A study conducted by the University of Michigan that surveyed pharmacies statewide showed that the more a child changes pharmacies or hospitals, the more likely they are to experience a medication error. With over 110 different pediatric medications currently being compounded daily, the change in process and concentration from pharmacy to pharmacy varies greatly. Parents or caregivers who have not been educated properly about the medications they are picking up risk creating a medication error for their child because the amount of the dose may be different due to a concentration that was compounded differently that the previous pharmacy. Michigan has since enacted uniform standards for compounding pediatric medications, and is the first state to recognize this problem and attempt to remedy it. A study, conducted after the Sentinel Event Alert was issued by the Joint Commission in 2008, looked at 960 random patient records from 12 different children's hospitals. The study found that there was an 11.1% rate of ADEs per admission. 22% of all errors were thought to be preventable, 17.8% could have been identified earlier and 16.8% could have been handled differently. Ninety-eight percent of those errors were shown to have mild, temporary harm and 2.8% resulted in hospitalization for a prolonged period of time. Now patients in Michigan can take prescriptions to any pharmacy and feel confident that Pharmacy A is dispensing the same concentration of medication as Pharmacy B. The University of Illinois at Chicago College of Pharmacy ran a study looking at specific items that cause medication errors known as triggers. The trigger approach assessed 931 patients from twelve different children's hospitals and was found to be useful in identifying medication errors for babies in the NICU. The study looked at common ADEs for adults taking certain medications and compared the neonate's reactions to that of the adult. Overall 2,388 triggers were identified or 2.49 per patient. 97.2% of the ADEs resulted in temporary harm and required intervention. 2.8% required hospitalization and the nature of the events led to permanent harm. Vanderbilt University has created a patient safety tool called STEPStools, or Safety Through Enhanced e-Prescribing Tools. This tool has been designed to help calculate the appropriate dose for children based on their age and body development. STEPStools currently looks at 120 of the most commonly prescribed pediatric medications and works electronically with any e-prescribing tool available. The tool is programmed to alert the prescriber any time there is an underdose or overdose of a medication ordered. Manufacturer Responses After the extensive media coverage regarding dosing errors with heparin, the manufacturer changed the appearance of the 10,000 units per mL vial versus the appearance of the 1,000 units per mL vial to help avoid further confusion. The same has been done with several look-alike, sound-alike medications, as well as medications that are available in multiple strengths. The Joint Commission recommends the use of technology to help reduce medication errors. Smart pumps warn when a dose entered does not seem feasible for the weight that has been inputted. Cardinal Health has been improving upon their Alaris pumps to include pediatric weight ranges as a requirement before programming the pump. If a dose is outside the weight range, the pump will not start. Government Involvement In 2009, the US Food and Drug Administration (FDA) stepped in and required manufacturers of over-the-counter (OTC) medications to change their packaging, label directions and dosing equipment that came with the medications in an effort to decrease the number of pediatric overdoses occurring at home. Even though this is not directly related to the pharmacy or its staff, it is an important reminder that part of our daily routine is ensuring that patients and caregivers are knowledgeable and comfortable in what they are dosing at home. We need to remain vigilant; when we see a parent with an OTC medication we shoudl ask if they have any questions, if they know how much to dose and if they need a better measuring device. All of these things will help reduce the number of medication errors in pediatric patients. Because children are at a greater risk for medication errors than adults, ISMP and the Joint Commission are both working hard to develop useful tools for pharmacies to help reduce the number of medication errors associated with pediatric medications. ISMP has several tools available for both retail and hospital pharmacies that allow you to evaluate your current processes and identify specific weaknesses. They provide you with a starting point and tools to remove these weaknesses. The Joint Commission wants the health care team (pharmacies, prescribers, nurses) to standardize measurements, double-check dosages and improve the communication lines between departments and with the caregiver to ensure proper dosing occurs at all times. The Joint Commission has recommended using technology as a means to help prevent medications errors; however, they caution that this will not stop all errors and is only as good as its user and programmer. There is no guarantee that there will not be errors. Other Joint Commission recommendations include: ● Maintain pediatric formularies with posted policies for drug selection and use ● Limit the number of concentrations and strengths available for medications ● Use correctly calibrated unit-dose syringes for the delivery of oral medications ● Create pediatric focused satellite pharmacies that staff pharmacists and technicians with extensive training in pediatrics ● Create pre-printed weight based dosing forms ● Utilize the metric system whenever possible ● Weigh every patient before doing anything ● Work out every calculation, clearly documented, allowing the pharmacist to double-check everything ● Be a resource to other departments, patients and caregivers to ensure medication compliance and help reduce errors ● Create a pediatric medication committee that reviews all errors that have occurred and develops policies for avoiding the errors in the future ● Use a barcoding system with every medication and every patient ● Encourage error-reporting by all members of staff Medication reconciliation helps to reduce the number of medication errors that occur during the transition of care. Knowing what prescriptions a child was given at home when they arrive at the emergency department ensures that they are not given more of the medication too soon. Medication reconciliation also helps decrease the number of medication errors that occur with the transition of care between departments or hospitals and inpatient care facilities. In a study conducted in 2013, 33,070 hospital admissions between November 2011 and June 2012 were assessed. A complete review of each patient's chart showed a decrease in medication errors from 5.9 errors per 100 patients previously recorded to only 2.5 errors per 100 patients. Developing medication reconciliation in every hospital has been a goal of the Joint Commission since 2005. Barcoding systems have been shown to help minimize medication errors by almost 47%. Barcoding systems ensure that the correct medication in the correct strength is pulled from the shelf and given to the correct patient as long as the barcode on the patient has not been tampered with. Barcoding systems are not entirely foolproof with pediatric medications because a majority of them have to be compounded. A barcoding system ensures that all of the ingredients have been pulled safely; however, it does not ensure that they were compounded using the correct amounts, in the correct order, using aseptic technique if necessary. Support The support for standardizing pediatric medications is overwhelming. Allen Viada, executive vice president for ISMP, stated that pharmacy services for children should have heightened attention at all times and, Some hospitals may have large pediatric populations, but don't have enough pediatric specialists working in the pharmacy. In order to improve the number of pediatric errors that keep occurring, it is important to invest more resources into developing and having pediatric specialists and equipment. It only takes one catastrophic medication error to show we're not all doing enough to prevent errors from occurring in children - our most vulnerable patients. Deborah S. Wagner, PharmD, pediatric pharmacology and safety expert. One of the most challenging [things] is that almost all medications are made and packaged for adults. This means taking extra calculations in forming pediatric doses, leaving more opportunities for error. Peter Angood, MD, Vice President and Chief Patient Safety Officer at the Joint Commission Conclusion Traditional methods used to detect medication errors in the pharmacy include voluntary reporting, profile reviews and direct observation. Studies conducted by the Joint Commission and Institute for Safe Medication Practices have convinced pharmacies to begin looking at how they handle pediatric medications. Many pharmacies are focusing on e-prescribing and computerized physician order entry, establishing medication reconciliation job titles, relying more on barcoding systems and changing up the way they stock look-alike, sound-alike medications. There have been changes made to the way medications are sent home with families including the type of paperwork and how it's worded, along with measuring devices that are calibrated for better, more accurate use. In an effort to minimize medication errors due to ambiguous orders, incomplete orders, or math errors, CPOE, pre-printed packets, lab order forms and prescription pads are all recommended for daily use. References Baker, Kenneth R; Pharmacy Training: More than Just Filling Prescriptions. Drug Topics, May 1, 2009. Baker, Kenneth R; Reducing Your Risk: Medication Errors - The Value of habit. Drug Topics, January 28, 2008. Donald, T. (2008). Joint Commission Targets Pediatric Medication Errors: Accrediting organization issues Sentinel Event Alert calling for increased vigilance against errors in children. Pharmacy Practice News. Durgin and Hanan; Pharmacy Practice for Technicians. Delmar Cengage, 2009. Gebhart, Fred; Quality Assurance in the Pharmacy.Modern Medicine, August 15, 2010. Levy, Sandra; Make no Mistake About It: Chain Pharmacies are Finding Innovative Ways to Combat Medication Errors. Drug Topics, July 9, 2007. Pediatric Safety Newsletter: Medication Errors. (2010). Pediatric Emergency Care Applied Research Network. Radwan, Catherine; Pharmacy Technicians Face States' Scrutiny, Regulation. Modern Medicine, August 25, 2009 Taylor, D. N. (2013). Reducing the risk of harm from medication errors in children. Health Services Insights. University of Illinois, Chicago College of Pharmacy. (n.d.). Vecchione, A. (2008). Pharmacists say more needs to be done to prevent pediatric medication errors. Drug Topics: Voice of the Pharmacist. www.jointcommission.org. (2010, 9 20). Retrieved 06 02, 2014 Learning Activity What areas of the hospital are responsible for keeping medication errors under control? Are pediatric medication errors restricted to hospital pharmacies? What can be done by members of other pharmacies to ensure that pediatric medication error rates decrease? Idea in Brief Medication errors are prevalent in every form of pharmacy and occur in every age group. The purpose of this CE module is to alert you to the numbers involving pediatric patients and inform you of the tools available to help decrease error rates. Idea in Practice Pharmacists and pharmacy technicians need to be aware of all possible ways medication errors can occur and learn about the tools available for evaluating their current medication use processes. This article discusses the requirements and recommendations put forth by the Joint Commission and the Institute of Safe Medication Practices and suggests different tools that can help reduce medication error rates in the pediatric population.