InformRx. Managing Chronic Hyperkalemia. By Pam Scandrett, R.Ph. Risks of High Potassium Levels CLINICAL & REGULATORY NEWS BY PHARMERICA

Transcription

1 Managing Chronic Hyperkalemia By Pam Scandrett, R.Ph. CLINICAL & REGULATORY NEWS BY PHARMERICA JAN/FEB 2019 Potassium (K+) is found inside skeletal muscle, liver, and red blood cells. Normal levels of potassium are meq/l. The body maintains this narrow range by correcting imbalances by increasing K+ secretion and redistributing K+ inside the cells, with most of the K+ excretion occurring through the kidneys and a smaller amount excreted by the GI tract. Risks of High Potassium Levels When K+ serum concentrations are greater than 5.0meq/L, hyperkalemia results. Hyperkalemia can be induced by an acute or chronic condition. Most cases of hyperkalemia are acute episodes, while chronic hyperkalemia is frequently caused by impaired renal excretion. In either situation, the clinical consequences of hyperkalemia can be significant. Severe hyperkalemia (K+ levels exceeding 6.0 meq/l) can lead to cardiac arrhythmias and sudden cardiac death. Hyperkalemia can cause muscle weakness and is a common reason chronic kidney disease (CKD) patients need dialysis. Moreover, the presence of or the risk for hyperkalemia may lead to patients receiving suboptimal medication therapy due to clinicians avoiding or prescribing lower doses of medications that may induce hyperkalemia. Causes of hyperkalemia include dietary changes. Salt substitutes that patients may utilize in an effort to decrease their sodium intake likely include continued on page 2

2 PHARMACY NEWS Managing Chronic Hyperkalemia, cont. a K+ salt. In addition, a heart-healthy diet includes foods that are high in potassium, including fruits, vegetables, and whole grains. In a patient with renal impairment, these dietary changes can result in hyperkalemia. In other cases, patients with certain disease states may have up to a 50% incidence of hyperkalemia, including diabetes, congestive heart failure, and chronic kidney disease. As glomerular filtration rate (GFR) declines, so does the patient s ability to excrete K+. In addition, medications that are commonly prescribed for these disease states frequently cause hyperkalemia, including angiotensin-converting enzyme inhibitors (ACE Inhibitors), angiotensin receptor blockers (ARBs), aldosterone receptor antagonists, and direct renin inhibitors. As these treatments have become more common for treating these disease states, so has the incidence of hyperkalemia. Other medications commonly used may also induce hyperkalemia by various mechanisms, including beta-blockers, digoxin, NSAIDs, Heparin, tacrolimus, and cyclosporine. Treatment Options For prevention, potassium-wasting diuretics, including loop and thiazide diuretics, have been shown to significantly decrease the risk for developing hyperkalemia. However, careful monitoring is required to watch for hypokalemia or worsening renal function due to hypovolemia. To treat the condition, there are several options: For chronic hyperkalemia, treatment can begin with dietary modifications and discontinuation or dose reduction of medications that may be causing hyperkalemia. However, continuing some of these medications to treat their disease states may provide clinical benefit so a risk-benefit analysis of each medication in the patient s profile is very important. Sodium Polystyrene Sulfonate (SPS) is a cationexchange resin that was approved in 1958 for the treatment of hyperkalemia. Its mechanism is to exchange sodium ions for potassium ions in the GI tract. It is available as an oral suspension or as an enema. The absorption of other medications may be reduced if administered within three hours of SPS. Although still frequently utilized clinically, its efficacy is debated due to its lack of supported data. Recent market shortages have also made use of SPS problematic. Patiromer (Valtessa) is also a cation-exchange resin that was approved in 2015 for the treatment of nonemergent hyperkalemia. It is available as a powder to be mixed with water for an oral suspension. It is non-absorbable, binding to potassium in the GI tract to reduce absorption. It begins working within 7 hours, and maintains its effect for 24 hours. Patients should be monitored for hypomagnesemia and gastrointestinal adverse effects with this treatment. Sodium Zirconium Cyclosilicate (Lokelma) was approved in May This agent is also a nonabsorbable potassium binding agent that acts in the GI tract. It appears to have a quicker onset of action, beginning to have an effect in a little over an hour. It is available powder packets to be mixed with water for administration. Other medications should be separated from SZC administration by 2 hours. For more information contact your PharMerica Consultant Pharmacist. 2 JAN/FEB 2019

3 F-TAG FOCUS F-Tag Focus: Medication Storage By Pam Scandrett, R.Ph. Making sure refrigerated medications are stored appropriately is a very important task for nursing facility staff. Below are some guidelines from PharMerica s P&P Manual and the CDC website for proper storage of these medications: a) Refrigerators storing medications should be maintained between degrees Fahrenheit. It is to set the thermostat to target a temperature of 40 degrees. A thermometer should be placed in the refrigerator and a temperature log utilized to ensure that a consistent temperature is maintained. b) Unopened insulin products should be stored in the refrigerator. When opened, the insulin products should be dated and may be stored at room temperature. c) Since vaccines that are not stored appropriately will lose their potency, the CDC recommends checking storage temperatures twice daily. Do not store vaccines in a dormitory-style combination refrigerator/freezer unit since it can pose a significant risk for freezing vaccines. Do not store vaccines in the drawers or the doors of refrigerators either because temperatures in these areas are more unstable. The best practice is to store vaccines in the center of the refrigerator, in the original packaging, in designated storage trays positioned 2-3 inches from the refrigerator walls. d) Refrigerated products should be stored in closed, labeled containers and separated by route of administration. Food utilized for medication administration should be separated as well. Any other food (e.g. employee lunches, activities refreshments, etc.) should not be stored in the medication refrigerator. Target a temperature of 40 degrees. The CDC website has a variety of resources available regarding vaccine storage and handling. See storage/index.html. 3 JAN/FEB 2019

4 CLINICAL CORNER MDS Section N: The New DRR Requirement By Shannon Caddell, Pharm.D. October 1st has come and gone so all nursing facilities should have their plans implemented for the new MDS Section N requirements. One of the most notable elements of the Improving Medicare Post-Acute Care Transformation Act (or IMPACT Act) of 2014 is the requirement that a drug regimen review (DRR) be conducted upon a resident s admission and any clinically significant issues be addressed by a physician by midnight of the next calendar day. This review and the attestation of its completion must be recorded in Section N of the MDS. The Quality Measures Data captured on the MDS will be used as part of fiscal year 2020 payment determinations. For purposes of Section N, the DRR includes the following tasks: Medication reconciliation Review of all medications a resident is currently using (including supplements, TPN and oxygen orders) to identify, and if possible, prevent clinically significant medication adverse consequences This new DRR requirement differs from the traditional monthly review conducted by the consultant pharmacist in several ways. The primary difference is that CMS does not mandate that this review be done by a pharmacist, but CMS defers to the facility procedures to determine who conducts it. Examples provided during the CMS training webinars included facility nurses, dispensing pharmacists and consultant pharmacists. continued on page JAN/FEB 2019

5 CLINICAL CORNER MDS Section N, cont. For a typical admission, there are three opportunities for this DRR to be completed. The first is with the admitting nurse, who reconciles the admission orders with the attending physician to ensure the medication list is accurate and appropriate. Once this step is complete and the orders are sent to the dispensing pharmacy, the second step is for the pharmacy to review the orders for appropriateness of dose, allergies and drug interactions. If there are any clinically significant issues identified, the facility will be notified. The third opportunity is for a consultant pharmacist to conduct an interim Medication Regimen Review (IMRR) upon facility request. This review should be done as close as possible to the admission, readmission or transition of care and reported on the 5-day PPS (Part A) scheduled assessment. Once a clinically significant issue is identified and reported to the nursing facility, there is a strict time frame mandated for physician response and implementation of corrective action. Specifically, this response must be implemented by midnight of the next calendar day after notification. PharMerica has developed a form for use by the facility to assist in this process. (Fig. 1) The form below is available from your consultant pharmacist for use by facility staff in documenting the DRR follow-up. This form will also be used by the dispensing pharmacy when clinically significant issues are identified. Section N requirements for this response time do not just apply to issues identified at admission. The time constraints apply to any clinically significant issue identified throughout the Med A stay, including findings from the routine monthly consultant visit. Make sure to communicate with your consultant pharmacist and establish procedures for managing these reported issues. It is important to note that Clinical Significance is in the opinion of the clinician that identifies the issue. Routine issues that do not impose an immediate risk of harm are not included in this requirement. Reserving the label of Clinical Significance for truly deserving issues will ensure that this process is manageable. For more information contact your PharMerica consultant pharmacist 5 JAN/FEB 2019

6 MEDICATION SPOTLIGHT Medication Spotlight: XOFLUZA (BALOXAVIR MARBOXIL) By Brian Garcia, PharmD XOFLUZA (baloxavir marboxil) was approved in October 2018 and is currently available for the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours. XOFLUZA is one of four antiviral agents called neuraminidase inhibitors that are approved for the treatment of influenza. The others are oral Tamiflu (oseltamivir), IV Rapivab (peramivir), and oral inhalation Relenza (zanamivir). These agents work to prevent the viral particles from spreading throughout the body by inhibiting viral replication. They are moderately effective for the treatment of infections with susceptible viruses, reducing the duration and severity of symptoms. In a placebo-controlled trial of 200 patients, XOFLUZA helped patients recover from the symptoms of the flu in 2.3 days compared to 3.3 days (33% faster). XOFLUZA was also tested in a head-to-head clinical trial against oseltamivir with 455 patients receiving XOFLUZA and 377 patients receiving oseltamivir. The reduction of duration of flu symptoms was similar with XOFLUZA compared with oseltamivir. Treatment with neuraminidase inhibitors should always be initiated as soon as possible, but no later than 48 hours after the resident is symptomatic since these medications are most likely to be beneficial only before the virus has spread. Candidates for antiviral treatment include residents with severe disease (requiring hospitalization or evidence of lower respiratory tract infection) or who are at high risk. All adults >65 years of age and all residents of nursing homes or other chronic care facilities are considered a high-risk patient population. According to the CDC, all long-term care facility residents who have confirmed or suspected influenza should receive antiviral treatment immediately. Additional recommendations for Influenza Outbreak Management in Long-Term Care Facilities from the CDC are available at this link: flu/professionals/infectioncontrol/ ltc-facility-guidance.htm XOFLUZA is the only oral agent available as a one-time dose. It should be administered as one 40mg dose (two 20mg tablets) in patients weighing <80kg (176 lbs) or one 80mg dose (two 40mg tablets) in patients weighing >80kg within 48 hours of onset. There are no dosage adjustments for patients with renal or hepatic impairment. In patients with mild to moderate renal and hepatic impairment, there were no clinically important effects. XOFLUZA was not studied in patients with severe renal or hepatic impairment. XOFLUZA has no evidence of efficacy in bacterial infections. XOFLUZA should not be co-administered with dairy products, calcium-fortified beverages, polyvalent cationcontaining laxatives or antacids, or oral supplements such as calcium, iron, magnesium, selenium, or zinc. Limited adverse reactions were documented in studies, with 2% of subjects experiencing gastrointestinal problems including diarrhea and 2% of subjects experiencing nasopharyngitis. For more information on XOFLUZA, ask your PharMerica consultant pharmacist or visit JAN/FEB 2019