DOFETILIDE PACKAGE INSERT PDF

A year-old man was admitted to the hospital for a total knee arthroplasty. During the admission process in the early evening, the surgical resident restarted his maintenance home medications, including oral dofetilide an antiarrhythmic agent taken every 12 hours. In the electronic health record, drugs ordered for "q12 hour" dosing are scheduled for 6 AM and 6 PM by default. The overnight nurse saw that the morning dose was scheduled to be given at 6 AM, but the patient was scheduled to leave for the operating room before 6 AM, so she gave the dose early, at 4 AM.

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A year-old man was admitted to the hospital for a total knee arthroplasty. During the admission process in the early evening, the surgical resident restarted his maintenance home medications, including oral dofetilide an antiarrhythmic agent taken every 12 hours.

In the electronic health record, drugs ordered for "q12 hour" dosing are scheduled for 6 AM and 6 PM by default. The overnight nurse saw that the morning dose was scheduled to be given at 6 AM, but the patient was scheduled to leave for the operating room before 6 AM, so she gave the dose early, at 4 AM. During his preoperative assessment at around 6 AM, the patient was noted to have severe QTc prolongation on his electrocardiogram, putting him at high risk for torsades de pointes, a sometimes fatal arrhythmia.

Considering the acute ECG changes prior QTc intervals were normal , surgery was canceled and the electrophysiology service was consulted. The electrophysiology fellow felt that the 4 AM dofetilide administration likely contributed to the arrhythmia. Dofetilide is known to be associated with QTc prolongation if administered too early or at excessive doses. Further investigation revealed the patient also took his previous night's dose later than usual, at 10 PM.

Consequently, rather than having received his dofetilide doses 12 hours apart, the 2 doses had been given only 6 hours apart. Neither the surgical resident nor the nurse responsible for administering the drug was aware of the risks associated with deviation from the strict hour dosing interval, and neither had asked the patient about the timing of his last dofetilide dose.

The patient was monitored on telemetry for a few days, and surgery was delayed until the return of his QTc to baseline. After this case, the hospital added dofetilide to a list of drugs that could only be ordered by a specialty service. Although all medications carry risk of patient harm when used in error, some medications are riskier than others. These are known as high-alert medications. Dofetilide, an example high-alert medication, is an oral Class III antiarrhythmic medication used for the conversion to and maintenance of normal sinus rhythm in patients with atrial fibrillation or atrial flutter.

It can cause QTc prolongation in a dose-dependent manner. Therefore, increases in the plasma concentration of dofetilide—which may occur due to overdose, too frequent dosing, drug—drug interactions, or decreased renal function—elevates the risk of induced arrhythmias. National recommendations exist regarding designation of high-alert medications e.

Rather, The Joint Commission requires hospitals to develop their own high-alert medication list and to implement a process for managing these medications. Even if they had, this case illustrates that simply identifying a medication as high-alert may not be enough to prevent errors from occurring.

While identification of high-alert medications is the first step to preventing harm, developing robust safeguards for their use is even more important. Without a detailed error-prevention plan implemented for each high-alert medication or medication class, creating a high-alert list does little more than meet a regulatory requirement. Some hospitals may rely solely on low-leverage, or relatively ineffective, risk reduction strategies such as high-alert labels on pharmacy bins or dispensed medications or double checks by nurses during administration.

One strategy to ensure that error-prevention plans are comprehensive is to create safeguards in every node of the medication-use process. This strategy is used below to discuss the dofetilide case. That designation should trigger the development of risk reduction strategies, which should be implemented before the medication is used at the institution. These strategies should be available in an institution-specific protocol readily accessible to practitioners. Several strategies could be employed during the prescribing process.

First, there should be a thorough medication reconciliation at all care transitions. At the time of admission, complete medication reconciliation should include documentation of the timing of the last dose, with subsequent timing based on that last dose's timing. Considering the risks associated with dofetilide, we believe that prescribing should be restricted to clinicians with appropriate expertise.

The hospital instituted this restriction after the medication error in this case. Prospective pharmacist verification of medication orders is an important step in error prevention. For select high-alert medications, hospitals should delineate the parameters that a pharmacist should verify and document. For example, verification of a dofetilide order should include checking the patient's dose, renal function, QTc interval, time of the last administered dose, and concomitant medications for drug—drug interactions.

Some hospitals may not require prospective pharmacist verification of orders written in the perioperative setting, thus bypassing this safeguard.

Wrong-time errors are the most prevalent administration errors. The Centers for Medicare and Medicaid Services CMS require that hospitals specify which medications are considered time-critical scheduled medications, those for which "an early or late administration of greater than thirty minutes might cause harm or have significant, negative impact on the intended therapeutic or pharmacological effect.

For non—time critical scheduled medications, the allowed administration window for a medication that is dosed twice-daily is one hour before or after the scheduled time. Additionally, pertinent information should be available at the point of care as for time-critical scheduled medications.

Many electronic health record EHR systems can alert a nurse attempting to administer a medication outside the acceptable administration window. All patients should be monitored for effectiveness and toxicity after administration of a medication.

Prescribers and nurses should be aware of the signs and symptoms of both. In this case, the patient's QTc interval was measured as part of the preoperative assessment, but the surgeons and nurses may not have known that use of dofetilide mandates monitoring of the electrocardiogram for QTc prolongation.

For medications with required monitoring parameters, EHR systems may be able to link medication and monitoring orders so that both are ordered simultaneously. Besides detailing monitoring parameters, medication orders should also specify subsequent actions to be taken e.

For providers and health care systems, they also include Elements to Assure Safe Use, which may require prescribers to have specific training, pharmacies and practitioners to be certified, and patients to be enrolled in a registry. Although there may no longer be FDA requirements for prescribing and dispensing of the medication, the risks associated with the drug still exist, and institution-specific risk reduction strategies should still be implemented.

Acute Care Edition. Your high-alert medication list—relatively useless without associated risk-reduction strategies. April 4, ; Principles of a sound drug formulary system. Coalition Working Group; June ASHP guidelines on the pharmacy and therapeutics committee and the formulary system.

Am J Health Syst Pharm. Cohen MR. Preventing prescribing errors. In: Cohen MR, ed. Medication Errors. ISBN: Medication errors observed in 36 health care facilities. Arch Intern Med. Prevalence and nature of medication administration errors in health care settings: a systematic review of direct observational evidence.

Ann Pharmacother. Revised hospital guidance for pharmaceutical services and expanded guidance related to compounding of medications. October 30, Assuring safety of inherently unsafe medications: the FDA risk evaluation and mitigation strategies. J Med Toxicol. Use quotes to search for an exact match of a phrase:. Published September Approach to Improving Safety. Structured Hand-offs. Continuing Education. Safety Target. Specific to High-Risk Drugs. Resource Type. Setting of Care.

Clinical Area. Target Audience. Health Care Providers. Error Types. Cognitive Errors "Mistakes". Facebook Twitter Linkedin Email. The Case A year-old man was admitted to the hospital for a total knee arthroplasty.

Preventing Harm With High-alert Medications in the Hospital Setting While identification of high-alert medications is the first step to preventing harm, developing robust safeguards for their use is even more important. Prescribing Several strategies could be employed during the prescribing process.

Order verification and dispensing Prospective pharmacist verification of medication orders is an important step in error prevention. Administration Wrong-time errors are the most prevalent administration errors. Monitoring All patients should be monitored for effectiveness and toxicity after administration of a medication. Take-Home Points High-alert medications, those that bear a heightened risk of causing significant harm when inadvertently misused, warrant precautions at each node of the medication-use process.

The risks associated with the medication and the safeguards to mitigate them should be known to patients, prescribers, pharmacists, and nurses. Certain medications are required by the FDA to have a Risk Evaluation and Mitigation Strategy, and all hospitals and practitioners must follow the outlined specific safety procedures.

Tikosyn [package insert]. Related Resources. Eric G. Arpana Vidyarthi, MD. Elizabeth A. Henneman, RN, PhD.

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Dofetilide (Tikosyn)

To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. The structural formula is. The chemical name for dofetilide is: N -[4-[2-[methyl[2-[4-[ methylsulfonyl amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide is a white to off-white powder.

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Wrong-Time Error With High-Alert Medication

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