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Reducing hospital Readmission: warfarin

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Warfarin (Coumadin®, Jantoven®), an anticoagulant used in the prevention and treatment of thromboembolic disorders, is used in as many as 12% of residents in nursing homes. Adverse medication events related to warfarin are a significant contributor to hospitalization among older adults. According to a 2011 study published in the New England Journal of Medicine, warfarin accounted for about one-third of all emergency hospitalizations due to adverse medication events in this patient population.

The annualized cost to treat medication-related hospitalizations is staggering. Based on a 2014 report released by the Office of the Inspector General (OIG), 37% of adverse events within 35 days or less following admission to a skilled nursing facility (SNF) were medication-related, and 66% of those events were considered preventable. Medication-related events accounted for approximately 35% of adverse outcomes requiring hospitalization, resulting in just under $58 million in cost for the study period of about one month. Among events resulting in significant harm and even death, circumstances related to anticoagulant therapy such as supratherapeutic (e.g., excessive bleeding) and subtherapeutic conditions (e.g., venous thromboembolism) were cited by the

OIG. Gurwitz, et. al. studied the safety of warfarin therapy in nursing home residents and found almost one-third of events were considered preventable. Those events categorized as serious or life-threatening were preventable 57% of the time, resulting in the authors’ conclusion that more serious events are usually preventable.

The OIG recommended that the Centers for Medicare & Medicaid Services (CMS) educate surveyors on reviewing nursing home practices for identifying and reducing adverse events, including adverse medication events. In July 2015, CMS released a memorandum announcing focused surveys to evaluate medication safety systems. This document included an Adverse Drug Event Trigger Tool to guide surveyors and facilities in identifying areas of risk to mitigate poor outcomes associated with certain medication classes, including anticoagulants like warfarin.

Developing a patient-centered approach to ensure appropriate prescribing and monitoring of warfarin therapy is essential to improve patient safety and reduce the risk of adverse outcomes, including hospitalization. Best practices include evaluation of your facility’s system to ensure

is required in patients with renal or hepatic impairment.

Linzess labeling contains a Boxed Warning regarding use in pediatric patients up to 6 years of age. Linzess is contraindicated in neonates, infants, and children up to 6 years of age. It is also contraindicated in patients with known or suspected mechanical GI obstruction. Patients with current symptoms (e.g., abdominal pain) that may suggest mechanical GI obstruction should be medically evaluated before using Linzess. Linzess should not be administered to patients with severe diarrhea.

appropriate ordering, dispensing, administration and monitoring of warfarin therapy. In addition, response to subtherapeutic (e.g., adjusting warfarin dose timely) and supratherapeutic INRs (e.g., holding warfarin, oral Vitamin K per current guidelines) is an important aspect that may be scrutinized during the survey process. The American College of Chest Physicians (ACCP) provides evidence-based guidance to assist in evaluating appropriate prescribing and monitoring of anticoagulant therapy in your facility and is a great place to start when Ask your Consultant Pharmacist

how they can help today.

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Reducing Hospital Admissions continued from page 1

Budnitz, et. al. Emergency Hospitalizations for Adverse Drug Events in Older Americans. N Engl J Med 2011;365:2002-2012.Gurwitz, et. al. The Safety of Warfarin Therapy in the Nursing Home Setting. Am J Med. 2207;120:539-544.Guyatt, et. al. Executive Summary Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141(2)(Suppl):7S-47S.

developing a program for your facility. As many adverse events related to warfarin therapy may be viewed as preventable, it is crucial to ensure you have an adequate system in place to track and monitor therapy.

Your Consultant Pharmacist routinely evaluates anticoagulant therapy to ensure appropriate systems are in place to minimize risk associated with use of these high-risk medications and is an excellent resource for information and education for your nursing team.

InformRx medICatIon sPotlIght

To review the OIG report, please visit the following link:

http://oig.hhs.gov/oei/reports/oei-06-11-00370.pdf CMS Adverse Drug Event Trigger Tool may be accessed at the following link:

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-47.pdf

Linzess is a gastrointestinal (GI) agent that increases intestinal fluid and decreases GI transit time. Linzess is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).

The typical adult dose of Linzess for IBS-C is 290 mcg by mouth once daily. The typical dose of Linzess for CIC is 145 mcg by mouth once daily. The maximum dose for both indications is 290 mcg by mouth per day for adult and

geriatric patients. Linzess should be administered at least 30 minutes before the first meal of the day on an empty stomach. Loose stools and increased stool frequency may occur if a high fat breakfast is consumed. Capsules should be swallowed whole; do not break or chew. Linzess should be stored in the tightly closed original container, which contains a desiccant package. Linzess must be protected from moisture and cannot be repackaged.

The most common adverse reactions associated with Linzess are diarrhea, abdominal pain, flatulence, headache, viral gastroenteritis and abdominal distension. No dosage adjustment

medication spotlight: linzess (linaclotide)

For more information on Linzess, please visit: www.linzess.com

One of the simplest tags to avoid during your survey is F431, yet it remains one of the most commonly cited CMS f-tags. This regulation requires that facilities have a system for recording the receipt and disposition of all controlled drugs. In addition, an accounting of all controlled drugs must be maintained and routinely reconciled. Most facilities place emphasis on this aspect of F431. However, the more common citations stem from the portion of the regulation that states:

“Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles. This includes the appropriate accessory and cautionary instructions, and the expiration date when applicable.”A best practice for avoiding this citation is to train nursing to perform routine inspections of medication storage areas and to instill accountability for thorough inspection of each medication prior to its administration to each resident. While inspections performed by pharmacy personnel on a monthly or quarterly basis are also a good idea, daily inspections by nursing staff remain essential. If nursing fails to regularly check, it only takes seconds to achieve non-compliance with simple failure to date a multi-dose vial. To ensure patient safety, nurses should verify expiration dates when comparing the MAR to the product label during med pass.

F-tag Focus: all hands on deck to avoid the Common F431

medication carts and rooms should be kept clean, organized and locked/secured when unattended by nursing.

Medication carts and rooms should be kept clean, organized and locked/secured when unattended by nursing. This lessens the risk for medication errors, reduces medication administration time and minimizes the amount of time to perform storage compliance inspections of med storage areas.

When receiving medications from the pharmacy, nurses should inspect labeling to ensure proper storage, keeping in mind that medications for internal use should be stored separately from those designated for topical or external use. Medications requiring refrigeration should be stored at a temperature of 36˚F to 46˚ F. Each refrigerator should contain a thermometer that is checked on a regular basis and with temperature documented on a log for verification. Any damaged packaging or labeling should be reported to the pharmacy.

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Emergency kits should also be inspected for exterior labeling that indicates the earliest expiration of kit contents. When items are removed, the label should be verified to include the expiration date prior to use and the kit re-secured per policy. Discontinued or expired medications should be removed and properly discarded or returned per pharmacy procedure to reduce risk of administering these medications.

Nurses should conduct vigilant and immediate checks of storage areas upon the arrival of surveyors, and should continue checks each shift during the survey.

PharMerica provides a number of resources to assist with medication storage compliance, including inspection forms and lists of Medications with Shortened Expiration Dates contained within the PharMerica Survey Preparation Kit, as well as in-servicing. In addition, you may schedule additional routine inspections by our team of nurse consultants to compliment your internal QAPI process.

Ask your Consultant Pharmacist or contact PharMerica at 877-874-2768.

F-tag FoCus

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Warfarin is the most frequently prescribed oral anticoagulant, with nearly 33 million prescriptions issued annually. Warfarin inhibits the formation of blood clotting factors and is used to prevent and treat blood clots in the lungs or extremities, as well as clots

associated with atrial fibrillation or heart valve replacement. Warfarin is also indicated to reduce the risk of recurrent MI or stroke in patients who have experienced myocardial infarction.

Warfarin is considered a narrow therapeutic index drug, and patient response to a standard dose can vary widely. Changes in patient lifestyle, diet, or health status can greatly affect the action of warfarin, so careful monitoring of INR (International Normalized Ratio) and adjustment of warfarin dose to target INR is very important. Target INR ranges are typically 2 to 3 or 2.5 to 3.5, depending on indication.

Despite monitoring, long term care facility residents receiving warfarin for anticoagulation therapy may experience supratherapeutic or elevated INR. Patients experiencing

oral Vitamin K for warfarin Reversal

In the nursing home setting, oral vitamin K is the gold standard of treatment when reversal of the InR is desired and indicated.

INRSupra-therapeutic, but less than 4.5

4.5 to 10

Greater than 10

elevated INR are at increased risk for bleeding. Previously, it was thought that an INR over 9 should be treated with oral vitamin K, which reverses the effects of warfarin and allows the formation of clotting factors. New guidance published in 2012 suggests that oral vitamin K treatment is typically not recommended until the INR is greater than 10.

Oral vitamin K is preferred over subcutaneous/intramuscular vitamin K for warfarin reversal and treatment of elevated INR. Patient response to subcutaneous vitamin K can be unpredictable, and it has been shown to be less effective than oral or intravenous (IV) vitamin K. One study suggested that after treatment with subcutaneous vitamin K, fewer than 50% of

management of supratherapeutic InR

patients will achieve an INR that is within normal limits.

Both oral and IV vitamin K are effective in returning INR to therapeutic ranges within 24 hours of administration. While IV vitamin K does have a faster onset of action than oral, it is associated with increased risk for fatal anaphylaxis and should be reserved for patients experiencing life-threatening bleeding.

In the nursing home setting, oral vitamin K is the gold standard of treatment when reversal of the INR is desired and indicated. The use of IV vitamin K should be reserved for cases of active and serious bleeding. Subcutaneous/intramuscular vitamin K is less effective than oral vitamin K and should be avoided.

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Management StrategyReduce or skip warfarin doseMonitor INRResume warfarin when INR is in therapeutic rangeHold 1 to 2 doses of warfarinMonitor INRResume warfarin when INR is in therapeutic rangeHold warfarinGive oral vitamin K 2.5 to 5 mg PO, even if not actively bleedingMonitor INR and resume warfarin at a lower dose once INR is in range

NotesDose reduction may not be needed if INR is only slightly elevated

Vitamin K not routinely recommended unless there is active bleeding, urgent surgery is needed, or other bleeding risk factors are present

The IV formulation of warfarin can be given orally; mix with orange juice to improve the taste

Sources: American College of Chest Physicians/Pharmacists Letter