Medication Safety

Abstract

Journal of Pharmacy Practice and ResearchVolume 44, Issue 3 p. 132-137 Medication SafetyFree Access Medication Safety First published: 25 September 2014 https://doi.org/10.1002/jppr.1002AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat US SAFETY BRIEFS Trainer EpiPen Used During Code A serious error with an EPIPEN (EPINEPHrine) trainer device was reported. The patient had been given premedications to lessen the risk of an infusion reaction from CARBOplatin treatment. (A boxed warning in the CARBOplatin prescribing information warns about an anaphylactic-like reaction.) Five minutes after starting the CARBOplatin, the patient exhibited facial flushing and a sudden need to use the restroom. The infusion was stopped, but on the way to the restroom, the patient became short of breath and lightheaded. The patient's nurse opened a carton of EpiPens and administered what she thought was EPINEPHrine by pressing a pen against the patient's outer thigh for 10 s. During transfer to an inpatient unit, the patient had an arrest. Cardiopulmonary resuscitation was initiated, and automated external defibrillator paddles were applied, but no shock was advised by the automated external defibrillator. Cardiopulmonary resuscitation continued and a second EpiPen was administered. The patient responded with a pulse but did not regain consciousness. The next day, it was discovered that an EpiPen trainer device, which contains no EPINEPHrine, was first administered to the patient. Currently, the training device is available with two different labels – an older version with ‘training device’ across the top of the pen and a newer version more clearly marked ‘TRAINER’ on one side (Figures 1 and 2). Figure 1Open in figure viewerPowerPoint Actual EpiPens. Figure 2Open in figure viewerPowerPoint Trainer devices, front view (bottom) and back view (left). However, the font on the other side is small, and the pens otherwise appear very similar. Packaging both in look-alike cartons all but guarantees an error will eventually happen. We have commented previously about the availability of training devices and demo products in patient care areas (28 November 2013), and specifically about EpiPen auto-injectors with a trainer device (22 September 2011). As mentioned in these articles, training devices and demo products should not be allowed in patient care areas. They should be reserved for the classroom. ISMP has previously asked Mylan, the EpiPen manufacturer, to offer a purchasing option that does not include trainer devices – this is BY FAR the best solution to prevent confusion. However, the last time we spoke with the company, we learned it plans to continue packaging the drug as is for now. The company also said that individual pens do not need to be stored in their cartons. Therefore, we highly recommend removing trainer devices from the carton and either discarding or storing them in a non-patient care area by themselves. Also, pharmacy staff should be alerted that pharmaceutical companies are co-packaging other ‘active’ device products with ‘inactive’ trainers for more and more products. Redesign is in order to better distinguish trainer devices from those containing medication. Generic auto-injectors are available without a trainer device (although training devices are available for staff and patient education), and AUVI-Q, the ‘talking’ auto-injector, is distributed with a trainer that verbally announces it is not a real pen. [ISMP Medication Safety Alert 27 February 2014] ISMP Canada Identifies Themes Associated With Fatal Medication Events in the Home Medication safety in the home is an important public health issue. Almost half of all Americans have taken at least one prescription medication in the last month,1 and more than three-quarters have taken an over-the-counter (OTC) medication.2 Almost two-thirds of Americans take at least one medication daily to treat a chronic health problem.3 Most of these medications are taken in the consumer's home, group home or other residential or community setting. In these settings, the risk of medication errors is ever present as consumers with variable health literacy4 and unlicenced healthcare personnel undertake the complex processes associated with safe medication management. To learn more about medication errors that happen in the home, our sister organisation, the Institute for Safe Medication Practices (ISMP) Canada, collaborated with several provincial Offices of the Chief Coroner and Chief Medical Examiner in Canada5 to conduct an analysis of medication events associated with deaths in the community setting.6 The goal of the analysis was to better understand the challenges faced by unlicenced healthcare personnel and consumers when managing medications in the home, and to identify opportunities to prevent similar tragic events in the future. This novel analysis uncovered clear themes and contributing factors that led to the fatal events. We believe these findings are noteworthy and valuable to US healthcare professionals, as there is good reason to believe that the same issues are causing fatal medication errors in US (and Australian) homes. Investigations of 122 fatal medication events spanning 6 years (2007–2012) were reviewed by an interdisciplinary team at ISMP Canada. Of these, 45 events occurred in a consumer's home, group home or other residential setting. In all of the 45 cases, the medications were administered by the consumer, family members or unlicenced healthcare personnel. The overarching theme linking the 45 events was that of knowledge deficits leading to various patient safety risks. These fell into three key areas: knowledge deficits related to misperceptions about medications, knowledge deficits related to signs and symptoms of toxicity and knowledge deficits about specific medications. ISMP Canada has published a detailed account of its analysis this month,6 which is summarised with permission below. Knowledge Deficits Related to Misperceptions about Medications The largest category of knowledge deficits involved misperceptions about the medications, including a failure to appreciate the general risks associated with prescription and OTC drug therapy. Most of the deaths involved an intentional therapeutic overdose, therapeutic sharing or unsafe storage of medications. Intentional therapeutic overdose: ‘If one is good, two will be better’. A number of events involved a prescription or OTC medication that was taken or given at a higher dose than prescribed or recommended on the package. Either extra doses were taken, dosing instructions were disregarded, or ‘as needed’ doses were used routinely. In the analysed events, it appears that most consumers or unlicenced healthcare personnel lacked awareness that a higher dose would increase the risk of side effects and serious toxicity, particularly with OTC medications. The following is an example of a fatal error in this category. An elderly woman with peripheral vascular disease died because of complications from overuse of an OTC Chinese herbal medicine containing methyl salicylate. The medicine was intended to be applied once or twice daily on the legs to provide relief from arthritic pain. The woman was frequently seen applying the medicine at least three or four times daily and would hide the medicine from the rest of the family after being reminded to use it less often. Overuse of the herbal medicine led to multiple medical problems, which contributed to her eventual death. Therapeutic sharing: ‘What works for me will work for you’. In a few instances, well-meaning people shared their prescription medications with others. However, they were unaware that a medication's effect is highly dependent upon the individual's medical conditions, tolerance to the medication and the pharmacologic properties of the drug itself. Many drugs require individual assessment, dosing and monitoring, and cannot be safely shared from one person to another. Some consumers felt their symptoms were not being appropriately addressed by their healthcare provider, which may have led them to consider recommendations from a friend. An example in this category follows. A man with chronic alcoholism and chronic pain from a work injury was found dead at home. A fentaNYL 100 mcg/h patch was found on his body, although the drug had never been prescribed for him. The man had told his wife that the patch had been provided by a friend. His death was attributed to fentaNYL toxicity combined with alcohol toxicity in an apparent opioid naïve person. Unsafe storage: ‘Does it really matter where I keep my medications?’ In this category, death occurred when medications were accessed and taken by others for whom the medication was not intended, particularly children. Pre-pouring medications and unsafe storage of drugs contributed to the events. Opioids caused most of the deaths in this category. A young child died after ingesting some of her father's liquid methadone dose. The child's father had taken part of the dose and mixed the remainder with orange juice in a cup that was accessible to the child. The child was later observed drinking what appeared to be juice. The following morning, the child could not be awakened and subsequently died in the hospital. Knowledge Deficits Related to Signs and Symptoms of Toxicity Opportunities to mitigate harm or prevent death may exist even after the occurrence of a medication event. Unfortunately, in many of the events analysed, caregivers or family members did not know or recognise warning signs of toxicity, which hindered timely recognition of trouble and resulted in missed opportunities to rescue the consumer. Analysis revealed that the majority of deaths falling under this category involved: unconsciousness mistaken for sleep, a sudden change in behaviour or a reluctance or hesitancy to seek help. Unconsciousness mistaken for sleep. In numerous events, family members or caregivers thought the person was sleeping when, in fact, he or she was unconscious. If unconsciousness is detected in a timely manner, there may be an opportunity to intervene and rescue the person from harm. Many caregivers or family members recalled hearing the person snore or make gurgling or groaning noises but did not know that unusual and irregular snoring is often a sign of dangerous stupor. In the events analysed, family members or caregivers had not tried to awaken the person until it was too late, assuming that ‘sleep is good’, as in the following example. A resident of a halfway house died from accidental oxyCODONE toxicity. He had been taking morphine and gabapentin prescribed by his family physician but was later referred to a pain specialist who suggested a long-acting oxycodone product. The written recommendation from the specialist was misinterpreted by the family physician, who prescribed a very high dose of oxyCODONE. After confirmation of the dose with the pharmacy and family physician, the medication was given to the resident for 3 days. On the day of death, the ‘sleeping’ (but really unconscious) resident was not ‘awakened’ for his scheduled dose of medication. Staff returned 2 h later and found the resident was not breathing. Sudden change in behaviour. Analysis identified cases in which there was a notable change in the consumer's behaviour, which might have represented an opportunity for timely intervention. Behaviour changes can be caused by drug toxicity. There are many medications used to treat a variety of conditions that can cause irregular behaviour if given too frequently or at a higher dose than required. In the analysed cases, the seriousness of the changed behaviour prior to death was not recognised. An example follows. A man with a history of mental illness was found dead at home. He had been taking multiple medications, including an opioid. A family member noted that, 2 days before his death, the man had been very groggy and did not seem like himself. The patient's death was associated with opioid toxicity. Reluctance or hesitancy to seek help. In a number of the cases reviewed, the consumers’ condition or pain had worsened, and they may have made changes in their medication regimen without seeking advice from a healthcare professional. In some instances, the consumer had told friends or family members of new or worsening symptoms lasting anywhere from 3 days to 3 weeks before death but had never reported these concerns to a healthcare provider. The following event illustrates a reluctance to seek help, even when an error was known to have occurred. A man lived in a communal house for people with various mental health issues. The owner of the house was responsible for distributing medications to the tenants at mealtimes. On the day of the event, the owner was ill and asked a family member to oversee the medication routine. Instead of receiving his usual medications, the man was given someone else's medications, including amitriptyline, QUEtiapine, loxapine and OLANZapine. When the family member realised the error, he immediately notified the owner of the house, who thought the medications the man had received were not significant enough to warrant medical attention. The man went to bed that evening and was found dead in his room the following morning. Knowledge Deficits Related to Specific Medications The most frequent medication classes identified during analysis of the fatal events included: opioids (20 cases) psychotherapeutic drugs (17 cases) insulins (5 cases) OTC medicines (5 cases) cardiovascular drugs (4 cases) anticoagulants (3 cases) anticonvulsants (2 cases) Several of these drug classes are also considered high-alert medications (e.g. opioids, insulin and anticoagulants). While the knowledge deficits associated with these medications are not generalisable to all events within the drug class, an illustrative example with insulin follows. An older man died after an inadvertent insulin overdose. He and his family were recent immigrants, and there was a language barrier. Day-to-day care was provided by his adult children, who prepared meals and administered medications, including insulin. They believed that additional insulin was needed to treat low blood glucose and continued to give insulin even when blood glucose readings were low. Conclusion ISMP Canada has highlighted important underlying knowledge deficits that contributed to preventable medication-related deaths in the home setting. The themes and contributing factors identified in this analysis illustrate the need to educate consumers about the medications they take at home. We must ensure that sufficient and timely information is effectively communicated to consumers, families, caregivers and unlicenced healthcare personnel about the following: the increased risk of side effects and serious toxicity if the dose of the medication is increased or the drug is taken more frequently (or less frequently) than prescribed or indicated the importance of following medication instructions on the label (for both prescription and OTC medications) the importance of seeking out assistance from a licenced healthcare provider if the directions for taking a medicine are unclear the potential side effects of medications, how to differentiate potentially dangerous effects from more benign ones and the actions needed to mitigate harm the signs and symptoms of toxicity necessitating intervention by licenced healthcare providers specific safeguards for the most frequent medications involved in these fatal events, particularly high-alert medications such as opioids (e.g. how to evaluate the level of sedation and signs of toxicity, safe storage) the need to communicate to a licenced healthcare provider any changing or worsening symptoms related to the medications and conditions being treated, or unusual or sudden behavioural changes the importance of reporting all medication errors to a licenced healthcare provider a plan to assess symptoms and medication effects (e.g. pain control when taking opioids) at regular intervals appropriate to the clinical situation REFERENCES 1National Center for Health Statistics. Prescription drug use continues to increase: U.S. prescription drug data for 2007-2008. NCHS Data Brief. 2010 Sep; 4. Available from: URL: www.cdc.gov/nchs/data/databriefs/db42.htm 2Consumer Healthcare Products Association (CHPA). The value of OTC medicine to the United States. January 2012. Available from: URL: www.chpa.org/ValueofOTCMeds2012.aspx 3Kotz D. Overmedication: are Americans taking too many drugs? US News, Health. 2010 Oct 7. Available from: URL: www.ismp.org/sc?id=302 4Coleman EA, Smith JD, Raha D, Min S. Posthospital medication discrepancies: prevalence and contributing factors. Arch Intern Med 2005; 165: 1842– 7. 5 ISMP Canada. Deaths associated with medication incidents: learning from collaborative work with provincial Offices of the Chief Coroner and Chief Medical Examiner. ISMP Can Saf Bull 2013; 13: 1-5. Available from: URL: www.ismp.org/sc?id=303 6 ISMP Canada. Deaths associated with medication incidents occurring outside regulated healthcare facilities. ISMP Can Saf Bull 2014; 14: 1– 6. [ISMP Medication Safety Alert 27 February 2014] Basal Insulins Incorrectly Withheld You may be surprised to learn that nurses sometimes inappropriately hold basal insulin doses (daily or every 12 h) when a patient's blood glucose is normal at the time a dose is due. This may be appropriate for mealtime or short-acting insulin products, but not basal insulins that can last for up to 24 h, such as insulin glargine (LANTUS) or insulin detemir (LEVEMIR). These events occurred with medical patients, not patients undergoing surgical procedures for whom it may have been appropriate to withhold doses or partial doses if they were not eating post-operatively. When a basal dose is withheld, the patient's fasting blood glucose the following morning is likely to rise. In the hospital, staff found patients with blood glucose readings in the 200–300 mg/dL range. This error is more likely to be noticed if pharmacy prepares basal insulin doses and investigates when the doses have not been administered. One hospital told us that they were seeing a few cases per week until they looked into the situation and made changes. The hospital's education department chose this as a topic for a program. The hospital also has changed their Lantus labels, adding a reminder, ‘Don't hold without MD order’. [ISMP Medication Safety Alert 13 March 2014] Testing Needed For 4200 Patients After Pen Misuse Once again, a US hospital must contend with the fact that thousands of the hospital's patients may have received an insulin injection from an insulin pen previously used for another patient (<www.ismp.org/sc?id=325>). In this recent event, patients are being notified of possible transmission of blood-borne pathogens and being told they should be tested for hepatitis and human immunodeficiency virus (HIV), although the risk is low. No actual cases of disease transmission have been tied to any of the previous ‘outbreaks’ we have published. However, there is strong evidence that retrograde travel of blood carrying haemoglobin, red blood cells and squamous cells into the pen cartridge occurs after injection (<www.ismp.org/sc?id=326>). So it will not be surprising if transmission is eventually documented. In this latest case, apparently one of the nurses at the hospital said she believed that reusing insulin pen reservoirs on multiple patients was an acceptable practice (<www.ismp.org/sc?id=327>). This problem is well known and not easily overcome with employee education and ongoing monitoring. Patients should be educated to not accept their insulin injection from an insulin pen unless they see their name on an attached label (<www.ismp.org/sc?id=328>). [ISMP Medication Safety Alert 27 March 2014] Angeliq – Not A Birth Control Pill! ANGELIQ (drospirenone, estradiol) is a hormone-based medicine used to relieve the symptoms of menopause. Unfortunately, we are aware of errors where it was prescribed improperly as an oral contraceptive. Our sister organisation, ISMP Canada, recently received two reports. In each case, a physician provided a woman with samples of Angeliq to take as birth control. Both women took Angeliq for several months until the samples were finished. The mistakes were discovered when the women took prescriptions for further supplies of Angeliq to their pharmacies and referred to them as ‘birth control pills’ (<www.ismp.org/sc?id=330>). Angeliq has a number of similarities to birth control pills that might have played a role in the mix-up. The labelling and packaging design is similar to that of birth control pills. It is available as a 28-day blister pack. ‘Angeliq’ also sounds like a woman's name – many birth control pills also have female-sounding names (e.g. PORTIA, YASMIN). In addition, neither the outer nor the inner package of the Angeliq sample pack has any information pointing out that the medicine is to be used for symptoms of menopause. Most important, the hormones contained in Angeliq appear similar to the ingredients in birth control pills: a progestin and oestrogen component. However, the dose of progestin in Angeliq is less than that used in birth control pills, and the potency of the oestrogen used in Angeliq is also different from that of birth control pills. So women using Angeliq instead of an oral contraceptive could become pregnant. And that is exactly what happened to a woman we heard from recently through our consumer error reporting program (<www.consumermedsafety.org>). Her doctor had given her Angeliq for birth control, and now she believes she is pregnant. Alert those individuals who might prescribe oral contraceptives about this risk. Ideally, consider a popup alert for prescriber order entry systems. [ISMP Medication Safety Alert 10 April 2014] New Connectors Coming For Enteral Feeding Tubes Later this year, the International Organization for Standardization (ISO) will introduce new design standards for enteral feeding device connectors. Introduction of the new connectors is crucial to patient safety because the current Luer-type connectors have a universal design that allows connections between devices that serve completely different functions (e.g. enteral tubing connected to a tracheostomy tube inflatable cuff or an IV line). The new enteral connectors will be introduced by The Global Enteral Device Supplier Association (GEDSA), an international group of enteral feeding device manufacturers, distributors and suppliers that has worked closely with ISMP, the Joint Commission, the Association for the Advancement of Medical Instrumentation (AAMI), the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), Premier Safety Institute, Novation and the Oley Foundation, a non-profit organisation that supports those requiring home intravenous infusions and tube feedings. While tubing misconnections are less of a concern in the home, the new, safer connectors will be introduced globally. So it is important to understand how the change will impact both hospital and home enteral nutrition. GEDSA has a campaign in place called Stay Connected 2014. The campaign goal is to assure that, by the time the connectors reach the market, everyone who uses an enteral device will be aware of the change, be prepared to transition to the safer connector and successfully adopt it. The new global design standards ensure that all manufacturers of feeding tubes, enteral administration sets and enteral syringes will use one standard design for the connector that will be universally adopted into practice. The enteral-specific design does not allow connectivity with any other type of connector. It also provides a locking feature that signals that appropriate connection has been made and remains in place. It has a female connector end for administration sets and syringes that fit into a male patient-access feeding tube port. The new standards will impact syringes as well as feeding tubes and feeding administration sets. Enteral-specific syringes with the new standard female connector will be required for connection to feeding tubes with the new standard male connector in order to administer feedings or flush lines. These changes are part of a larger initiative that will later introduce standards for connectors used in other applications. The initiative is designed to reduce tubing misconnections by making sure devices for different delivery systems are not compatible. Tubing misconnections are rare, but when they occur, patient injuries can be serious, life-threatening and even fatal. Manufacturers have been working together to develop a plan for introducing the new connectors. Transition connectors or ‘adapters’ are planned to allow new feeding/administration sets and syringes to connect to existing gastrostomy or jejunostomy tubes until the transition is complete. Feeding/administration sets with these adapters will start to be distributed in the fourth quarter of 2014. This will minimise any disruption to hospitals and consumers while allowing the use of the feeding tubes and feeding/administration sets already on hand until supplies are exhausted and the new ones are in place. Eventually, these adapters will be phased out. All major enteral device manufacturers are expected to comply with the new ISO standards. During the fourth quarter of 2014, customers ordering enteral administration sets will receive transition feeding/administration sets. Syringes used for flushing and boluses will be available with the new connector during the first quarter of 2015, and new enteral feeding tubes with an ISO standard connector will be available in the second quarter of 2015. By January 2016, the transition to new ISO standard connectors will be complete. At that point, the current universal Luer connector will no longer be available for any enteral feeding applications. Visit the Stay Connected 2014 website for updates (<www.stayconnected2014.org>). ISMP wishes to acknowledge Tom Hancock, Executive Director of GEDSA, for his collaborative work on this initiative and this article. [ISMP Medication Safety Alert 10 April 2014] Ten-Fold Error With Trailing Zero A few weeks ago, a pharmacist initially misread the maximum IV niCARdipine (CARDENE) dose on the GlobalRPh website as 150 mg/h when it actually listed the dose as ‘15.0 mg/h’. GlobalRPh indicated that the company was simply following the text of the official label which reads, ‘Initiate therapy at 50 mL/h (5.0 mg/h). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/h (2.5 mg/h) every 5 min (for rapid titration) to 15 min (for gradual titration) up to a maximum of 150 mL/h (15.0 mg/h), until desired blood pressure reduction is achieved’. GlobalRPh has now changed the way the dose is depicted (<www.globalrph.com/nicardipine_dilution.htm>), without using trailing zeros. We have asked the US Food and Drug Administration (FDA) to request the sponsor to make the same change in the approved label, as well. [ISMP Medication Safety Alert 8 May 2014] Actiq Is Not For Sore Throats! A hospital reported three events in which a provider attempted to order ACTIQ (fentaNYL citrate oral transmucosal lozenge) to treat a sore throat, mistaking the powerful opioid as a typical throat lozenge. In two cases, the pharmacist identified the error and contacted the provider. In the third case, the provider caught his own error. In each case, the patients did not have other opioids on their profiles, or a history of opioid use. Use of this product in opioid-naïve patients could have resulted in serious harm. The hospital where the events occurred is considering possible Information Technology (IT) changes. The hospital is also implementing safeguards to prevent further occurrences, including limitations on prescribing to pain management specialists, anaesthesiologists, haematologists, oncologists, palliative care and hospice providers. Strict limitations on prescribing, dispensing and distributing this drug are required by the Transmucosal Immediate Release FentaNYL (TIRF) Risk Evaluation and Mitigation Strategy (REMS), an FDA-required program designed to ensure informed risk-benefit decisions before initiating treatment, and appropriate use while patients are treated. Before enrolment in the TIRF REMS Access program, prescribers and pharmacists must review an education program (<www.ismp.org/sc?id=357>), successfully complete a knowledge assessment with a score of 100% and sign acknowledgement statements on the enrolment form. The hospital where these events happened is also implementing an automatic medication order form that includes criteria for use of the product that cannot be bypassed without completing the form. Due to the risk of fatal respiratory depression, Actiq is contraindicated in opioid-naïve patients. [ISMP Medication Safety Alert 8 May 2014] Volume44, Issue3September 2014Pages 132-137 FiguresReferencesRelatedInformation