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1 Clinical & Regulatory News by Pharmerica Urinary Tract Infection (UTI) Second Most Common Cause of Hospital Readmission within 30 days UTIs are prevalent and account for up to 22% of infections in LTC, making it the most common type of bacterial infection in LTC. They are second only to heart failure (28% vs 31%) as the most common cause for hospital readmissions within 30 days. UTIs account for around 5% of emergency department visits in those 65 years and older. In suspected infections, UTIs account for 30-60% of antibiotic prescribing in LTC. The CDC recommends that all nursing homes take measures to improve antibiotic prescribing practices and reduce inappropriate use to reduce adverse events, prevent resistance and afford better outcomes. The CDC Core Elements of Antibiotic Stewardship for Nursing Homes notes that two of the four infection specific interventions to improve antibiotic use involve UTIs: 1. Reduce antibiotic use in asymptomatic bacteriuria (ASB) 2. Reduce antibiotic prophylaxis for prevention of UTI Older LTC residents have risk factors for UTIs that include: Diabetes Stroke BPH or urinary obstruction Dementia or cognitive impairment Indwelling catheters or other drainage devices Drugs that reduce urinary flow (e.g. anticholinergics, antipsychotics) Drugs that increase the risk of dehydrations (e.g. diuretics) Very few studies support the use for UTI prophylaxis in older adults as it places them at increased risk for resistance and side effects. Minimizing or avoiding the use of medications that are strongly anticholinergic, (e.g. diphenhydramine, fluoxetine, amitriptyline) may decrease the risk of UTIs. Your consultant pharmacist can work with your facility to identify suggested strategies for UTI prevention and appropriate antibiotic selection. July/Aug 2016 Full details and resource documents available:

2 Clinical Corner Opioid Prescribing for Chronic Pain: New CDC Guidelines Released Earlier this year, the Centers for Disease Control and Prevention released new guidelines for prescribing opioids for chronic pain. 1 The guidelines provide recommendations for primary care clinicians who are prescribing opioids for chronic pain. It should be highlighted that these recommendations are not to be applied to treatment for active cancer, palliative care, or end-of-life care.* The guidelines address three major areas: Determining When to Initiate or Continue Opioids for Chronic Pain Opioid Selection, Dosage, Duration, Follow-Up, and Discontinuation Assessing Risk and Addressing Harms of Opioid Use According to the guidelines, rates of opioid prescribing vary greatly across states in ways that cannot be explained by the underlying health status of the population, highlighting the lack of consensus among clinicians on how to use opioid pain medication. Additionally, deaths from opioid overdose increased markedly while death rates from heart disease and cancer Before starting opioid therapy establish treatment goals with all patients, including realistic goals for pain and function... decreased over that same period. These factors led the CDC to conduct a clinical systematic review of the scientific evidence to identify the effectiveness, benefits, and harms of long-term opioid therapy for chronic pain. CDC recommendations for prescribing opioids for chronic pain outside of active cancer, palliative, and end-of-life care Determining When to Initiate or Continue Opioids for Chronic Pain 1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate. 2. Before starting opioid therapy establish treatment goals with all patients, including realistic goals for pain and function, and should consider how therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety. 3. Before starting and periodically during opioid therapy, clinicians should discuss with patients both known risks as well as realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy. Opioid Selection, Dosage, Duration, Follow-Up, and Discontinuation 4. When starting opioid therapy prescribe immediate-release opioids instead of extended-release/longacting (ER/LA) opioids. 5. When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, carefully reassess the evidence of individual benefits and risks when increasing dosage to 50 morphine milligram equivalents (MME)/ day, and avoid or carefully justify increasing dosage to 90 MME/day. 6. Recognize that long-term opioid use often begins with treatment of acute pain. When opioids are used Opioid continued on page July/Aug 2016

3 Clinical Corner Opioid continued from page 2 for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids. Clinicians should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed. 7. Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of initiation or escalation of opioid therapy for chronic pain. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids. opioid overdose, such as history of overdose, or substance use disorder, patients with higher opioid dosages ( 50 MME/day), or concurrently on benzodiazepine therapy. 9. Clinicians should review the patient s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months. 10. When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs. 11. Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible. 12. Clinicians should offer or arrange evidence-based treatment for patients with opioid use disorder (i.e. medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies). *All recommendations are category A (apply to all patients outside of active cancer treatment, palliative care, and end-of-life care) except recommendation 10 (designated category B, with individual decision-making required); see full guideline for evidence ratings. Assessing Risk and Addressing Harms of Opioid Use 8. Before starting, and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate strategies into the management plan to mitigate risk. This includes offering naloxone for patients with factors that increase risk for 1. * For this guideline, palliative care is defined as care that provides relief from pain and other symptoms, supports quality of life, and is focused on patients with serious advanced illness. End-of-life care is defined as care for persons with a terminal illness or at high risk for dying in the near future in hospice care, hospitals, long-term care settings, or at home. This guideline is not intended for patients undergoing active cancer treatment, palliative care, or end-of-life care because of the unique therapeutic goals, ethical considerations, opportunities for medical supervision, and balance of risks and benefits with opioid therapy in such care. For more information about Potentially Inappropriate Medications or other questions, contact your PharMerica Consultant Pharmacist or pharmacy. 3 July/Aug 2016

4 InformRx Medication Spotlight Medication Spotlight: NUPLAZID (pimavanserin) NUPLAZID (pimavanserin) is a selective serotonin inverse agonist with no appreciable binding affinity for dopamine, histamine, muscarinic, or adrenergic receptors. associated with increased morbidity and mortality, but reducing causative PD medications to address psychosis may increase or cause motor problems. NUPLAZID is the first antipsychotic therapy used in Parkinson s disease that does not block dopamine. NUPLAZID can reduce hallucinations without affecting motor performance. In one study, patients NUPLAZID is indicated as a using NUPLAZID experienced a long term, once daily (two 17-mg 37% improvement in PD psychosis tablets) maintenance treatment symptoms with no significant change for hallucinations and/or delusions in motor function. NUPLAZID is not associated with Parkinson s disease indicated for treatment of patients (PD) Psychosis. PD psychosis is a common non-motor with dementia-related psychosis unrelated to the hallucinations symptom of PD characterized by and delusions associated with hallucinations and/or delusions that PD psychosis. develop after diagnosis of PD and NUPLAZID may be taken without cannot be attributed to other causes. regards to food, and achieves More than 50% of patients with PD therapeutic levels after 12 days of will develop psychosis, but is often continuous therapy. NUPLAZID is unrecognized and underreported. safe in patients with mild to moderate Symptoms of PD psychosis are 4 July/Aug 2016 renal impairment (CrCl > 30mL/min), but is not recommended in patients with severe renal impairment (CrCl 30mL/min). NUPLAZID should not be taken by patients with hepatic impairment and should have dosage adjustments in patients concurrently taking strong CYP3A4 inhibitors or inducers. NUPLAZID, like other antipsychotic drugs, has a black box warning for increased mortality in elderly patients with dementia-related psychosis. NUPLAZID does prolong QT interval, and should be avoided in combination with other QT prolonging drugs. The most common adverse reactions in placebo-controlled studies that have >2% reporting were: nausea, constipation, peripheral edema, gait disturbance, hallucination (including visual, auditory, tactile, and somatic), and confusional state. For more information on NUPLAZID, please visit:

5 F-Tag Focus Decreasing F-Tag Deficiencies For Enteral Tube Medication Administration Errors related to medication administration via the G-Tube are most commonly cited at F322 and F 332/333 Medication Errors. However, if noncompliance with the administration of medication(s) via a feeding tube is identified, additional requirements are frequently investigated, e.g., F425 Pharmacy Services, F441 Infection Control and F329 Unnecessary Medications. Let us first define the F-Tags so that you can see how they apply to medication administration. F-Tag 322: NG Treatment/ Services The intent of this regulation is to ensure residents who are fed by a nasogastric or gastrostomy tube receive the appropriate treatment and services to prevent aspiration pneumonia, diarrhea, vomiting, dehydration, metabolic abnormalities, and nasalpharyngeal ulcers and to restore, if possible, normal eating skills. Care of the Feeding Tube: The frequency of and volume used for flushing should be defined, including flushing for medication administration. When a prescriber s order does not specifiy, this must be clarified. The facility staff should review current policies and procedures for medication administration via G-Tube, appropriately trained staff, and whether the facility has incorporated into its quality assurance activities a review of appropriateness and management of tube feedings. Now that we have identified the regulations as they pertain to medication administration via a G-Tube, let s review some specific processes that should be employed at all facilities. Know your Policy and Procedures for G-Tube medication administration. P&P Manual Policy 7.10 states: The nursing care center assures the safe and effective administration of enteral formulas and medications. Selection of enteral formulas, routes and methods of administration, and the decision to administer medications via enteral tubes are based on nursing assessment of the resident s condition, in consultation with the physician, dietitian and pharmacist. Utilizing the P&P for nursing medication administration will prepare the facility in this realm for surveyor inspections. P&P 7.1 (1-20) covers step by step procedures from start to finish that nursing staff must follow when administering medications via NG-tube or G-tube. P&P 7.10 (8-13) offers specific guidelines for administration. This includes medications that may or may not be crushed, mixing medications, flushing the tube, fluid restrictions, and administration of GI irritants. F-Tag 332/333: Medication Errors (1) The facility is free of medication error rates of five percent or greater; and (2) Residents are free of any significant medication errors. The intent of this regulation is that residents receive medications in accordance with physician s orders, manufacturers specifications, state requirements and standards of practice. The surveyor will determine if the staff member administers each medication separately and flushes the tubing between each medication. An exception would be if there is a physician s order that specifies a different flush schedule because of a fluid restriction. For a resident who requires fluid restriction, the physician s order should include the amount of water to be used for the flushing and administration of medications. NOTE: Failure to flush before and in between each medication administration is considered a single medication error and would be included in the facility s medication error rate calculation. It is vitally important to have nursing staff trained on guidelines and clinical procedures so medication administration via NG/G-tubes is performed correctly. To access a copy of the memo and related changes to the guidance listed above, visit: Transmittals/Downloads/ R127SOMA.PDF 5 July/Aug 2016