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This series brings you up-to-date information about medication safety issues and strategies to prevent medicationerrors. It draws on Australian incidents and US experience, including (with permission) material from ISMP MedicationSafety Alert! a bulletin published by the US Institute for Safe Medication Practices <www.ismp.org>. This series iscoordinated via the Committee of Specialty Practice in Medication Safety (Chair, Rosemary Burke, Director ofPharmacy, Concord Hospital, NSW). Australian incidents are collated and editorial recommendations made byPenny Thornton (Pharmacy Services Manager, The Children’s Hospital, NSW; <pennyt2@chw.edu.au>). US SAFETY BRIEFS
Mobile phones and e-mail could prevent harm.
A patient was accidentally given another patient’s drugs A female patient with pulmonary arterial hypertension and when the pharmacist realised the mistake, he (PAH), receiving Tracleer (bosentan) and Revatio attempted to reach the patient by phone. The patient did (sildenafil) went to the emergency department with not answer and the pharmacist kept trying but did not ischaemic chest pain and ECG changes. The physician get through until later that evening. By that time, the reviewed her drug list but did not know that Revatio was patient had already taken Cellcept (mycophenolate sildenafil or understand its contraindications. The patient mofetil), an immunosuppressant, instead of her new was given aspirin and sublingual nitroglycerin and later prescription for Zestril (lisinopril) to treat hypertension.
started on nitroglycerin infusion for continued chest pain Despite of all the communication technology available and elevated troponin-T. Organic nitrates are today, we tend to ask patients only for their home and contraindicated in any form, at any time, while a patient work phone numbers. Some patients may list their mobile is taking sildenafil. This contraindication is echoed in phone number as their home number because they do product monographs for the other phosphodiesterase 5 not have a landline. But we rarely ask patients to provide inhibitors, e.g. Cialis (tadalafil) and Levitra (vardenafil).
their mobile phone numbers or e-mail addresses. It makes In this case, the patient experienced no adverse effects sense to ask for this information to communicate better or blood pressure changes because an internist recognised the problem and stopped the infusion.
[ISMP Medication Safety Alert! 29 January 2009] Sildenafil is better known as Viagra, a drug approved forthe treatment of erectile dysfunction and is typically Lyrica-Lopressor mix-up
prescribed in 50 mg doses to be taken 1 to 4 hours before A patient with a history of atrial fibrillation was admitted sexual activity. When used to treat PAH, sildenafil is to hospital with an order for Lopressor (metoprolol) 100 typically prescribed in 20 mg doses to be taken three mg BID. The doctor’s handwriting was poor and the order times daily. Viagra has received widespread professional was misinterpreted and dispensed as Lyrica (pregabalin) and direct-to-consumer advertising, including mention 100 mg BID. The patient received three doses of Lyrica of associated contraindications. In this case, if the and experienced a run of temporally related atrial sildenafil had been prescribed and communicated under fibrillation. A nurse then recognised the error. Lyrica is the Viagra name, perhaps the physician would have used to treat pain due to nerve damage in patients with recognised the problem with co-prescribing nitroglycerin.
diabetes or shingles and is also used to treat pain in Revatio has the approved indication for treatment of PAH people with fibromyalgia. Lyrica is also used to treat (to improve exercise ability) and Viagra does not. The certain types of partial onset seizures. The patient had FDA approved Revatio as the new brand name not none of these conditions. Hospitals may want to add a because the drug has a new indication but because of computer alert about this newly reported look-alike drug the stigma PAH patients might associate with taking name pair. Matching the drug’s indication to the patient’s Viagra. Dual brand names for a single product are health condition is the best way to avoid confusion problematic when one of the product names is well between products with look-alike names.
established before the new product is launched. Further,patients with PAH frequently have concomitant coronaryartery disease, increasing the risk of receiving a nitrate.
Recommendations. FDA often requires companies to
[ISMP Medication Safety Alert! 29 January 2009] analyse whether a dual brand name or two different brandnames would be safest for a product marketed for two U looks like 4
different indications. If dual brand names are used, This handwritten order was misread as NovoLog ‘54 manufacturers could clearly warn patients and health units’ instead of the intended ‘5 units’. Although the professionals on the package label and the package insert word ‘units’ had been written out, the letter ‘u’ looked that the drug is available under both names. Health like the number ‘4’ and the remaining part of the word professionals can also reduce the risk of errors by ‘nits’ was read as ‘units’. The mistake was made by three conducting a thorough drug history and reviewing drug practitioners who either dispensed or administered the information if they encounter unfamiliar product names.
drug. The patient received the large dose of insulin and To help patients avoid taking the same product under required treatment for severe hypoglycaemia. This error different names, health professionals should encourage occurred despite the prescriber’s avoidance of the them to fill their prescriptions at the same pharmacy.
abbreviation ‘u’ for units. Electronic prescribing is one Patients with PAH who take Revatio should be way of reducing the risk of misinterpreting handwritten encouraged to note on their drug list that it is alsomarketed as Viagra.
[ISMP Medication Safety Alert! 29 January 2009] Journal of Pharmacy Practice and Research Volume 39, No. 1, 2009.
orders. Maintaining adequate space between the levels of distractability, preventing interruptions and numerical dose and unit of measure can also increase distractions is best accomplished by providing staff with correct interpretation of the dose. The hospital where the ability to control their exposure to disturbances. To this error occurred is considering requiring both a maximise staff concentration when performing critical numerical and written number dose (e.g. 5 [five] units) for all handwritten insulin orders, similar to outpatient minimise the potential for distractions in critical prescriptions for the quantity of controlled substances (e.g. 30 [thirty]). This order also included an error-prone teach workers to avoid interrupting co-workers for abbreviation, SQ – subcutaneous should be written out non-urgent reasons while they are performing medication-related tasks. Techniques include visual [ISMP Medication Safety Alert! 15 January 2009] cues (e.g. nurse wearing an orange safety vest whenadministering medications), physical barriers and Australian comment: The NSW TAG abbreviation
checklists to focus and refocus attention.
recommendation is just this – to use ‘subcut’.
Sound and noise. Noise can interfere with effective work
performance and pose a health hazard to patients.
USP’s safe practice environment chapter
Hospitals are noisy with studies reporting an average of The United States Pharmacopeia (USP) recently published 45 to 65 dB of noise with peaks between 85 to 90 dB.
its proposed new general chapter (1066) on ‘Physical Noise levels at shift change have been recorded as high environments that promote safe medication use’. The as 113 dB, well above the peak levels set by the chapter describes the optimal physical environment Environmental Protection Agency (EPA) – 45 dB day/35 needed to promote accurate medication use and how dB night and the WHO – 35 dB of background noise in anyone involved in the process can establish a safer patient rooms. The EPA requires ear protection for workers workplace. When justified by evidence and expert opinion, exposed to sound levels averaging 90 dB. Out of 58 standards are provided in five key areas—illumination, studies reviewed by the USP, 29 showed that noise interruptions and distractions, sound and noise, physical impaired performance, but seven showed it improved design and organisation, and medication safety zone.
performance. For example, in one of the seven studies, Illumination. Improper lighting has been a contributing
unpredictable but controllable sounds improved factor in some medication errors. In one case, poor prescription filling accuracy, which may indicate that lighting led to the incorrect attachment of tubing to a some environmental stimuli are needed to maintain patient-controlled analgesia unit, causing the drug to run alertness and attention. To maintain a safe level of noise, onto the floor. In another case, dicyclomine 10 mg capsules were used to fill a prescription for 20 mg capsules due to sound levels in medication use areas should be at poorly lit pharmacy shelves. Numerous studies have the level of conversation, 50 dB, slightly higher than shown that proper lighting improves accuracy and the EPA recommendation to ensure critical verbal efficiency of medication-related tasks. Studies have also information can be heard accurately. Total elimination found that lighting levels need to be increased for workers older than 45 years and when visual fatigue rises near provide a quiet area for staff to use during critical the end of the work shift. Based on the relationship between lighting and errors, the USP recommends the reduce noise and other sensory interference by employing activities, tools and design principles use fluorescent cool white deluxe lamps or compact such as installing materials that absorb sound.
Acoustical engineers can identify additional methods use adjustable 50-watt high-intensity task lights in for noise reduction. Periodically measure sound areas where critical tasks are performed, as well as levels in work areas by holding the meter away from on mobile medication carts, automated dispensing the body while standing in a working position and cabinets and in patient rooms for night time pointing the meter at the source of sound.
Physical design and organisation. The physical design
position all lighting to avoid glare on computer and organisation of the work space can influence the staffs’ ability to use information and perform tasks, for provide magnifying glasses to read labels with very example, the height of counters and drug storage areas can influence visibility. Studies have shown that clean lighting fixtures routinely (lighting levels can dispensing errors occur more frequently when decrease by 25% over 2 years without cleaning); medications are stored on cluttered shelves because the ensure illumination levels of around 100 foot candles items are more difficult to differentiate. The design of the in areas where critical tasks are performed in the work space can also contribute to poor lighting conditions, distractions and interruptions, high noise levels and periodically measure lighting using an illuminance unsafe medication safety zones. To reduce the risk of meter. Place the meter in key areas with the worker standing in a normal working position. To measure keep areas where medications are stored organised light in medication storage areas, take readings on and uncluttered, with at least 1 inch between distinct Interruptions and distractions. The MEDMARX data
ensure that the height of work counters and supply show that distractions are a causative factor in about areas enhance efficiency of tasks and visibility of 45% of medication errors. Co-workers asking for assistance were the most frequent sources of interruptions use adjustable fixtures (e.g. task lights, counters) to in one pharmacy study. As individuals have differing promote efficiency, visibility and safety.
Journal of Pharmacy Practice and Research Volume 39, No. 1, 2009.
Medication safety zone. The USP defines a medication
potassium level of 7.9 mEq/L. The first things that come safety zone as any critical area where medications are to mind when thinking about the effects of cotrimoxazole prescribed, transcribed, prepared and administered.
are serious skin reactions and crystalluria. However, Examples include work surfaces in a medication room or another and perhaps lesser known adverse effect of counter tops on medication carts, locations where concurrent use of Bactrim and lisinopril is hyperkalaemia.
prescribing decisions are made, pharmacies, and patients’ The trimethoprim component in Bactrim causes a bedsides or homes where medications are administered.
potassium-sparing effect, much like the potassium- Medication errors have been linked to the physical design sparing drug amiloride. Trimethoprim blocks sodium of medication safety zones as well as error-prone methods channels (particularly amiloride-sensitive sodium used within these zones to carry out medication-use channels) in the distal tubule of the nephron. This activities. The USP recommends that the drug preparation blockade inhibits potassium secretion into the urine, areas are designed so that critical processes are leading to reabsorption in the blood and possible conducted in a manner similar to work in the cockpit of hyperkalaemia. Prescribers, pharmacists and nurses need an aeroplane, i.e. the information necessary to make to be aware of this adverse effect of the trimethoprim decisions is readily available in a user-friendly format component in Bactrim. Patients at increased risk for and all together to support fact finding. The information cotrimoxazole-induced hyperkalaemia are those on high and components within safety zones should be arranged doses of Bactrim; those with renal impairment, (50% dose in a manner that promotes correct choices and decreases reduction is recommended for patients with a creatinine distractions according to the following principles: clearance 15 to 30 mL/min); those on other drugs that Importance – place important components in increase the risk of hyperkalaemia such as angiotensin convenient locations (e.g. locate information converting enzyme inhibitors, angiotensin II receptor regarding equipment function and troubleshooting blockers and potassium-sparing diuretics; those on diets with potassium-rich foods (e.g. tomatoes, raisins, figs, Frequency of use – locate frequently used items in bananas, papayas, pears, cantaloupe, mangoes) or those areas where they can be easily found to help prevent using potassium salt substitutes. To avoid this reaction, obtain a baseline BUN/creatinine, adjust the dose for Function – group items that are related to a function patients with renal impairment and periodically monitor together, such as syringes, needles and alcohol potassium levels in at-risk patients and those taking high doses of Bactrim. These recommendations should be Sequence of use – place items in an order that included as reminders in pharmacy computer systems supports the sequence needed to perform the task and electronic prescribing software.
correctly (e.g. sterile gloves encountered first when [ISMP Medication Safety Alert! 4 December 2008] opening dressing change kit). Standardise thedesign of bedside medication administration areas Alcohol abuse and hand sanitisers
so that information and supplies can be readily According to a recent letter (Am J Health Syst Pharm located. Standardise medical equipment (e.g. infusion 2008; 65: 2203-4), readily available dispensers of alcohol- pumps) to reduce mistakes during operation. Employ based hand sanitisers may be too inviting for patients technologies, such as electronic prescribing, bar- prone to severe alcohol abuse. The authors reported a coding and electronic medical records. Use case in which a hospitalised patient with a known history constraints (limit access/use) and forcing functions of ingesting rubbing alcohol and alcohol-containing (design aspect that allows correct performance only) hand sanitiser and mouthwash was witnessed ingesting to reduce errors with high-alert medications (e.g.
Avagard foam hand antiseptic (contains 62% alcohol) sequester neuromuscular blocking agents in an from a wall dispenser on two occasions. After the second intubation kit to prevent accidental administration occurrence, staff removed the hand sanitiser from the wall. The authors pointed out that patients with a history The USP urges health professionals to participate in this of non-potable alcohol ingestion require careful important standard setting chapter by providing assessment of abuse patterns in light of the availability comments and spreading the word to colleagues of alcohol-based hand sanitisers in hospitals. Their <www.usp.org/USPNF/pf/whatsInside.html>.
presence increases the risk of alcohol intoxication, falls, [ISMP Medication Safety Alert! 4 December 2008] and drug interactions. The authors recommendedtemporary removal of alcohol-based hand sanitisers from Cotrimoxazole-induced hyperkalaemia
wall dispensers when high-risk patients are present.
An 86-year-old female was being treated as an outpatient [ISMP Medication Safety Alert! 4 December 2008] for cellulitis in her left leg caused by methicillin-resistantStaphylococcus aureus (MRSA). She was taking two Misprogramming PCA concentration leads to
Bactrim DS (sulfamethoxazole 800 mg/trimethoprim 160 dosing errors
mg) tablets twice daily as well as oral lisinopril 20 mg ISMP has received a small but concerning number of daily for hypertension. Cotrimoxazole is commonly reports of overdoses with patient-controlled analgesia prescribed for urinary tract infections or prophylaxis/ (PCA) as a result of pump programming errors. Although treatment of Pneumocystis jiroveci pneumonia in every aspect of the PCA process has the potential for immunocompromised patients. Bactrim use has increased error, ISMP is especially concerned with errors related to because it is active against MRSA infections. The patient programming the concentration of the narcotic.
had been taking a typical Bactrim dose for MRSA skin Accidentally entering a higher than actual concentration infections, according to the Sanford Guide to of narcotic in a PCA pump results in the delivery of a Antimicrobial Therapy (38th edition), but she was lower dose than prescribed, which can be significant as admitted to the ICU with ventricular arrhythmia and a the patient’s pain may not be controlled. If increased Journal of Pharmacy Practice and Research Volume 39, No. 1, 2009.
dosing (and thus increased rate of infusion) is prescribed, dose and dose schedule that have been prescribed.
subsequent changes of the PCA syringe or bag—for In addition, a copy of any such reference should be which the concentration is then reprogrammed included in the patient’s chart, and the information correctly—may result in the delivery of more drug than readily available for use by pharmacy and nursing necessary, risking respiratory depression. At the same time, dosing errors caused by inadvertent programming all orders for cytotoxic drugs include the relevant of a lower-than-actual concentration of a narcotic into patient diagnosis. Given the variety of indications the PCA pump may result in the delivery of a higher dose for which cytotoxic drugs can be used and the wide than prescribed. These are the more dangerous errors variation in doses and administration schedules, that have led to adverse drug events, including fatalities.
members of the care team need specific diagnostic [ISMP Medication Report Analysis. Hosp Pharm 2008; information to confirm appropriate dose ranges.
Admission orders typically include the admissiondiagnosis, but some comorbidities may not be listed Near-miss involving cyclophosphamide
on admission. In addition, conditions diagnosed An intensive care unit patient was diagnosed with during the hospital stay may not appear in Wegener’s granulomatosis and the doctor ordered IV subsequent orders. Regardless of the indication, cyclophosphamide 2.2 g daily for 3 days. The pharmacist require that all orders for cytotoxic drugs include the who reviewed the order checked the patient’s medication patient’s weight (and height, if the body surface area profile in the pharmacy but could not identify the must be calculated) to allow staff to double-check indication for cyclophosphamide. Furthermore, given the dose of cyclophosphamide that had been ordered, the develop standard protocols for cytotoxic drugs pharmacist expected an accompanying order for the commonly used for non-oncology indications.
bladder-protective drug mesna, but there was no order Ensure that practitioners have ready access to the for this drug. The pharmacist contacted the ICU and was protocols and other drug information resources. For advised of the patient’s new diagnosis by a nurse. The example, at the hospital where the near miss occurred, pharmacist initiated a literature search because she the intravenous therapy manual has since been believed that the cyclophosphamide dose for an revised to include dosing for cyclophosphamide and autoimmune disorder such as Wegener’s granulomatosis other cytotoxic drugs used for non-oncology would be much lower than the prescribed dose. The literature review confirmed the pharmacist’s suspicions build optimal safeguards into the ordering process and she contacted the doctor. The doctor initially affirmed for cytotoxic drugs, regardless of indication.
the order as prescribed, but after discussing the matter Consider incorporating quality checks into pre- further and reviewing the information presented by the printed orders and electronic order entry systems, pharmacist, the doctor realised that he had intended to such as reference dose ranges and dosing schedules, order a dose of 220 mg. The doctor changed the order criteria for withholding or reducing the dose (e.g.
and expressed gratitude for the pharmacist’s follow-up.
threshold for absolute neutrophil count), a place to The following factors were identified as contributing to show dose calculations and a clear indication of the doctor had intended a dose of 4 mg/kg per day x 55 integrate predefined order sets and protocols into kg (patient’s body weight) for a total of 220 mg or computerised prescriber order entry and maximum- 0.22 g. However, when calculating the dose, the physician misread his handwritten note about the avoid use of dangerous dose designations such as weight-based dose. The handwritten note stated ‘4.0 trailing zeros. When cytotoxic drugs are ordered for mg/kg’ but the physician misread the amount as ‘40 the treatment of cancer, the protocols are readily mg/kg’ and consequently ordered 2.2 g; and available, and the drugs are ordered, dispensed and protocols for cytotoxic drugs used for non-oncology administered by trained health professionals. In indications were not readily available to either the addition, the high-alert nature of these drugs is well physician or the pharmacist. (In contrast, when a recognised in oncology practice, and stringent cytotoxic drug is ordered for an oncology indication, processes, including ensuring availability of the the facility requires that the current protocol be information required to process an order and printed from a provincial cancer web site and placed performing the necessary multiple checks, are routine.
in the patient’s chart. These oncology protocols are Similar system-based safeguards are required for publicly available and are accessible to all staff.) cytotoxic drugs used for non-oncology indications.
Recommendations. Procedures that govern the use of
[ISMP Canada Safety Bulletin. 30 October 2008] cytotoxic drugs for oncology indications are alsoapplicable when drugs such as cyclophosphamide areused for non-oncology purposes. This near-miss incidentexemplifies the value of ensuring that all orders forcytotoxic drugs are reviewed by a pharmacist with theskills for performing such reviews. The followingrecommendations were developed in collaboration withthe reporting facility:• the drug order specify the therapeutic protocol beingused. If a standard protocol is not readily available,require that the prescriber provide, before thecytotoxic drug is prepared, references for the specific Journal of Pharmacy Practice and Research Volume 39, No. 1, 2009.

Source: http://jppr.shpa.org.au/lib/pdf/med_safety/2009-03_MedSafety.pdf

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