Antibiotic Therapy: How long is long enough? By: David Milstein, C.Ph., BS, MHSA CLINICAL & REGULATORY NEWS BY PHARMERICA Antibiotics are highly regarded as safe and effective, but as with all medications, there are risks associated with their use, from the development of allergies and Clostridium difficile infections to increased antibiotic resistance. The growing bacterial resistance to antibiotics has been making headlines in the news and medical journals recently. As a result, prescribers face mounting pressures to reduce the risks associated with antibiotic resistance, and they are consistently prescribing shorter treatment courses. However, it is important for the prescriber to provide a treatment course that will adequately treat and prevent relapse. Several decisions may influence the length of therapy for antibiotic utilization: Choice of agent. Antibiotics work in one of two ways: either they are bactericidal, which kill the bacteria, or bacteriostatic, which inhibit the growth of the bacteria. The decision about which type of antibiotic to use depends on the bacteria count and the type of bacteria. A high count or quickly reproducing bacteria may require the use of a bactericidal drug, while a lower bacteria count or slower reproducing bacteria may permit the use of a bacteriostatic drug. Antibiotic s ability to penetrate and remain at the site of infection. Antibiotics penetrate different tissues in the body at varying rates. The site of the infection and the antibiotic s ability continued on page 2 MAY/JUNE 2018
PHARMACY NEWS Antibiotic Therapy, cont. to reach that site will affect the concentration of antibiotic in the infected area, as well as the length of the time the antibiotic stays at the infected site. Resident s immune status and bacteria causing the infection. Residents without hemodynamic issues may potentially be treated with shorter courses of therapy. For example, simple community-acquired pneumonia (CAP) may be treated with as little as five days of therapy. But if the resident s condition is complicated by bacteremia, or severe sepsis, a longer course of therapy is required. Additionally, because of the use of antibiotics in the past, different bacteria may be more resistant to the standard antibiotic indicated for a particular infection and may require a longer length of therapy, higher dose, or the addition of a second antibiotic. Within a few days of beginning therapy, improvements in the resident s hemodynamic condition, white blood cell count, temperature, oxygenation, and sometimes x-ray findings should be seen. Rechecking cultures is not always needed once the resident has started therapy, except with bloodstream infections. In fact, acquiring unnecessary cultures should be avoided because a positive culture without signs or symptoms of infection could lead to treating colonized bacteria. Once the resident s clinical symptoms are resolved, prescribers should consider terminating therapy. Recent studies have shown that there were no adverse reactions or rebound pneumonia when ending therapy for CAP early after symptoms have resolved compared to a full course of therapy. Prescribers can also utilize two new methods to determine antibiotic response and the duration of therapy: C-reactive protein (CRP) and procalcitonin tests. The procalcitonin test is more specific to bacterial infections and has been shown to For more information on Antibiotic Therapy, contact your PharMerica Consultant Pharmacist. Antibiotic Stewardship Facility Program PharMerica s Model Antibiotic Stewardship Facility Program can help keep you compliant with new requirements. Contact your Account Manager or Consultant Pharmacist for more details. reduce antibiotic therapy by between 23% and 25%. As prescribers decide the appropriate antibiotic and length of treatment, they should consider the potential benefits to shorter durations of therapies if clinically appropriate to help reduce the risk for development of resistance. As more research is done on short duration therapy, it may eventually become the standard of care. 2 www.pharmerica.com MAY/JUNE 2018
F-TAG FOCUS Practical Considerations for Managing PRN Psychoactive Medication Use in the LTC Setting By Shannon Caddell, PharmD How well is your facility managing PRN (as needed) psychoactive medication use? Phase II of the Centers for Medicare and Medicaid Services (CMS) Mega Rule went into effect on November 28, 2017, and as a result, facilities must have a defined process in place to prevent pharmacy-related F-tags on their next survey. Since the implementation occurred six months ago, it is important to understand how surveyors are addressing these issues so you know how to remain in compliance. With the new regulations, CMS implemented rules on PRN psychotropics (defined as any drug that affects brain activities associated with mental processes and behavior, including, but not limited to antidepressants, anti-anxiety, and sedative/hypnotics) as well as PRN antipsychotic medication use. PRN Psychotropics PRN psychotropics now have a 14- day limitation on the duration of the order with an option for extension if the prescriber documents the rationale in the medical record and indicates the duration on the PRN order. But how long can this duration be extended? Can it be indefinite? CMS answered this question in an FAQ document released in January 2018. Since the intent of the regulation is to address concerns about residents remaining on PRN medications for an inappropriate length of time, the FAQ states that inde inite does not meet the intent of the regulation and should not be used. Anecdotal reports from recent surveys suggest that 30 or 60 days as an extension time frame has been accepted by surveyors. It is imperative that the rationale for the duration and the designated extension time be documented in the clinical record. PRN Antipsychotic Medications PRN antipsychotic medications also have a 14-day limitation on each order, but with one important difference: this class of drug may not be extended beyond 14 days. If a prescriber wants to renew the order for another 14 days, he or she must perform an evaluation of the resident for the appropriateness of continuing the order a step clarified by CMS in the same January FAQ document. The required evaluation must include a direct examination of the resident by the prescriber and an assessment of their current condition and progress to determine if the PRN antipsychotic is still needed. A verbal or written report of the patient to the prescriber from nursing center staff does not constitute an evaluation. Surveyors will review the medical record as well as interview staff to assess compliance. continued on page 4 3 www.pharmerica.com MAY/JUNE 2018
F-TAG FOCUS Practical Considerations, cont. Tips for Compliance To comply with the new rules, here are some tactics you can implement. Identify all PRN psychotropics and antipsychotics that are ordered. PharMerica has developed reporting to assist in this task via our customer portal, ViewMasteRx, where you can subscribe to the Daily Psychotropic New Starts Report. This report highlights residents with a new psychotropic drug order during any specified time period, e.g., the previous day, previous week, etc. By reviewing this report on a daily basis, you can then view each new start to make sure that all appropriate documentation (duration, clinical rationale, evaluation, etc.) is noted in the clinical record. Beware the use of comfort packs in hospice patients. The CMS FAQ also addressed the use of PRN antipsychotics in hospice patients and their use for another purpose such as an antiemetic. No exception currently exists for these situations so the 14-day limitation is being strictly applied. As a result, it is important to be aware of the historical use of hospice comfort packs since, many times, the bundled orders include PRN Haldol or ABH gel (Ativan/Benadryl/Haldol). Be sure to work with your hospice provider to establish processes to only order those medications at the time they are needed rather than pre-emptively write orders based on hospice status alone. Remove medications after order expiration. An area of concern that has resulted in survey tags is leaving a medication in the cart after the order has expired. If an order for a PRN antipsychotic has elapsed 14 days but the medication remains in the cart, surveyors may cite a facility. To avoid a citation, facilities should add a PRN medication check to their internal cart check schedules and remove medications in a timely manner even if the prescriber has indicated they will come in to do an evaluation. Only return the medication to the cart after the prescriber completes the evaluation and writes a new order. Implement a PRN Psychoactive Order template. To ensure that all documentation is in place before an order is carried out, a PRN Psychoactive Order template can be utilized. The template should address each requirement of the regulation and include space for documentation as necessary. Only orders that have every field completed on the template should be submitted, which will greatly reduce the risk of having a non-compliant medication order. Your consultant pharmacist can assist with this template implementation. To access the CMS FAQ document and related changes to the guidance referenced above go to: https://www. cms.gov/medicare/provider-enrollment-and-certification/ GuidanceforLawsAndRegulations/Downloads/LTC-Survey- FAQs.pdf 4 www.pharmerica.com MAY/JUNE 2018
CLINICAL CORNER Survey Preparedness By Jeff Herr, PharmD Preparing for survey can be challenging and anxiety-provoking. But following a few survey preparation suggestions can help you get ready. 1. P & P Manuals. Remember that most of the functions your nursing staff performs are regulated by your nursing center Policy & Procedure (P & P) manuals, including those on nursing, infusion and IV, Antibiotic Stewardship, and any others your facility has implemented. Therefore, every nurse needs to know where the P&P manuals are and be familiar with the content. At your next staff meeting, ask your nurses if they can identify the location of the P&P manuals. If they cannot, that is a critical issue. Also, make sure you discard older manuals so there are no conflicting P&Ps available for viewing. Lastly, the manuals must be signed by all interdisciplinary team members annually to signify approval. 2. Infection Prevention. Your facility should have an Infection Prevention program fully implemented and known by all staff. All levels of staff should be following the determined parameters set by your interdisciplinary team for identifying when a resident has an infection (e.g. McGeers Criteria) as well as when to call the prescriber and with what information. Prescribers should be knowledgeable of facility protocols and procedures. After 48 to 72 hours, when additional information, including microbiology, radiographic and clinical information, is available, stops should be in place for confirming the antibiotic is still warranted, and more importantly, that it is effective against the organism. All members of the team should be up to date on what data to document and who to give documentation to for statistical analysis and trending of antibiotic utilization and resistance. Antimicrobial use assessments and tracking should reflect statistics that are useful in your Antibiotic Stewardship quality assurance meetings. 3. Med Pass. A large part of your survey includes the med pass and med room/med cart audits. Your Pharmacist Consultant and Nurse Consultants can make sure your team is ready by performing med pass, med room and med cart audits. Nursing Consultants can also perform such tasks as MAR to Cart or three-way audits to ensure everything is correct from the initiation of the medication order all the way to the MAR and administration to the residents. Infection control techniques are critical in this area and your entire team should be knowledgeable of and practicing appropriate procedures at all times. If you need assistance, your Pharmacist Consultant or Nursing Consultant can partner with you in survey preparedness. continued on page 6 5 www.pharmerica.com MAY/JUNE 2018
CLINICAL CORNER Survey Preparedness, cont. 4. Psychotropics. Psychotropic medication use is highly scrutinized by the state. Staff should be knowledgeable of the most recent regulations, including the Centers for Medicare and Medicaid Services Mega Rule. You should maintain clear documentation from interdisciplinary team psych meetings and ensure your care plan addresses minimal dose reductions on all psychotropic medications at least quarterly. While psychotropic dose reductions are not necessarily required, their utilization must be reviewed, considered for reduction, and documented a practice that reflects patientcentered care. All indications need to be accurate, and all behavior and side effects in this class of drugs must be monitored and visible on the MAR. Informed consents need to be given and documented and appropriate labs and assessments need to be completed within the appropriate time period. the interdisciplinary team must be reviewed and responded to with appropriate action occurring in a timely manner. All recommendations that are declined by prescribers based on clinical judgment must include the rationale behind their decision with accompanying medical justification and/or risk versus benefit statements. Declined recommendations without rationale will frequently result in cited deficiencies. By taking these steps with the support of your Pharmacist Consultant, your facility will be better prepared for a stress-free survey. 5. Medication Appropriateness. Your Pharmacist Consultant constantly looks at all medications and their appropriateness in terms of dosing, diagnosis/indication, organ function, disease state, allergy information, necessary lab work and interactions with the resident s other medications. Medication recommendations from the Pharmacist Consultant made to nursing, prescribers and For more information on Survey Preparedness, contact your PharMerica Consultant Pharmacist. 6 www.pharmerica.com MAY/JUNE 2018
MEDICATION SPOTLIGHT Medication Spotlight: TRELEGY ELLIPTA By Brian Garcia, PharmD For chronic obstructive pulmonary disease (COPD) patients, TRELEGY (fluticasone furoate, umeclidinium, vilanterol) is the first and only once-daily triple therapy treatment delivered in a single inhaler. TRELEGY is indicated for the maintenance treatment of COPD in patients who are on a fixed-dose combination of fluticasone and vilanterol for airflow obstruction and reducing exacerbations. It is also for patients in whom additional treatment of airflow obstruction is desired or for those already receiving umeclidinium and a fixed-dose combination of fluticasone and vilanterol. Triple Therapy TRELEGY combines an inhaled corticosteroid (ICS), long-acting beta2 adrenergic agonist (LABA), and long-acting muscarinic antagonist (LAMA) in one daily inhalation. It is available in the Ellipta delivery device, which is also used for Breo (ICS/LABA) and Incruse (LAMA) products. Patients should discontinue use of Breo and Incruse products the dose before initiating TRELEGY therapy. Guidelines recommend triple therapy with an ICS, LABA, and LAMA (the components in TRELEGY for group D patients, defined as those who have a high risk of exacerbations and airflow limitation and have more symptoms of COPD. COPD has two primary subtypes: 1. Emphysema: in which the air sacs of the lungs are damaged and enlarged, causing breathlessness. 2. Chronic Bronchitis: which is constant irritation and inflammation of the lining of the bronchial tubes. Administration TRELEGY is administered once daily, with no adjustments for renal or mild hepatic impairment. TRELEGY should be used with caution in patients with moderate to severe hepatic impairment, as systemic fluticasone exposure may be increased up to threefold. Patients should rinse their mouth out and spit after each use because of the risk of thrush associated with fluticasone. All LABA-containing products, including TRELEGY, have a Black Box Warning for asthmarelated death, and are NOT indicated for the treatment of asthma or the relief of acute bronchospasm. If a patient misses a dose of TRELEGY, and it is close to the next dose, they should skip the missed dose and not use two doses at the same time. Side Effects As components of TRELEGY are not commonly systemically absorbed, there are limited systemic side effects. Common side effects include higher risk of respiratory infections (<8%), including nasopharyngitis, upper respiratory tract infections, and pneumonia. Rare adverse events include cardiovascular abnormalities (< 2%), anaphylaxis (<1%), and angioedema (<1%). TRELEGY is only indicated for patients who have already been on Breo as dual therapy. The GOLD For more information on TRELEGY ELLIPTA, contact your PharMerica Consultant Pharmacist. 7 www.pharmerica.com MAY/JUNE 2018