Pharmacist CE LESSON. Reducing and eliminating high-risk medications in older adults 1 OCTOBER 2015

Transcription

1 By Tara Dymon, PharmD, BCACP, Clinical Pharmacist, Medicare Pharmacy Clinical Programs; Miranda Wilhelm, PharmD, Clinical Associate Professor, Southern Illinois University Edwardsville School of Pharmacy; and John Swegle, PharmD, Clinical Associate Professor, Applied Clinical Sciences and Clinical Pharmacist, University of Iowa, Mercy Family Medicine Reside Author Disclosures: Tara Dymon, Miranda Wilhelm, John Swegle and the DSN editorial and continuing education staff do not have any actual or potential conflicts of interest in relation to this lesson. Universal program number: H05-P Activity type: Knowledge-based Initial release date: Oct. 9, 2015 Planned expiration date: Oct. 9, 2018 This program is worth 2 contact hours (0.2 CEUs). Target Audience Pharmacists in community-based practice. Program Goal The goal of this lesson is to enhance the community pharmacists skills in evaluating therapy and making recommendations for patients who are using high risk medications to improve patient safety. Learning Objectives Upon completion of this program, the pharmacist should be able to: 1. Describe the medication measure, Use of High-Risk Medications in the Elderly (HRM). 2. Identify medications that are classified as high-risk medications. 3. Create alternate drug therapy recommendations resulting in the reduction or elimination of high-risk medications in older adults. 4. Discuss best practices for communicating therapy changes to patients and prescribers. 5. Discuss methods to successfully communicate recommendations for treatment alternatives to HRM. To obtain credit: Complete the learning assessment and evaluation questions online at DrugStoreNewsCE.com. A minimum test score of 70% is needed to obtain a statement of credit. Your statement of credit will be available at CPE Monitor (NABP.net). Your correct e-pid number must be included in your DSN CE profile to ensure transmission of credit to CPE Monitor. Questions: Contact the DSN customer service team at (800) Drug Store News is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Reducing and eliminating high-risk medications in older adults INTRODUCTION Despite known concerns associated with the use of certain medications in the elderly population, a study found that 21% of Medicare Advantage enrollees received at least one high-risk medication, or HRM, and almost 5% received at least two HRMs. 1 HRMs are those medications that generally should be avoided in patients ages 65 years or older, either because the adverse effects associated with that medication outweigh potential benefits, or because there are alternative medications available that are deemed to be safer. 2 Adverse effects that commonly qualify a medication to have a high-risk designation include sedation and cognitive impairment, which can both increase risk of falls in elderly patients. 3 Adverse drug events from the use of potentially inappropriate medications in older adults was estimated to cost more than $7 billion from 2000 to Several reasons have been suggested as to why high-risk medications continue to be prescribed despite the known concerns, including lack of awareness, cost and clinical inertia. 4 Some prescribers may be unaware of a medication s high-risk status, or may not recognize the adverse effects. For example, an adverse effect may be seen as a new symptom, and a new medication is prescribed, rather than discontinuing the offending agent. Many of the medications classified as high risk are older and less expensive than their newer, safer alternatives, so prescribers and/or patients may be reluctant to change. Patients also may have been on a high-risk medication for a number of years before turning 65 years old; therefore, the prescriber may not wish to change the medication, especially if there are no apparent problems (clinical inertia). This is an area where community pharmacists may directly impact reducing and/or eliminating the use of highrisk medications. In an effort to improve patient safety and reduce costs associated with adverse drug events, the Centers for Medicare and Medicaid Services requires Medicare Advantage plans to report the percentage of their enrollees that receive a highrisk medication. Plans are trying to minimize the number of HRMs taken by their enrollees. Community pharmacies and pharmacists should work with health plans to reduce the use of HRMs by patients. Community pharmacists have many opportunities within workflow to address medication therapy problems. In regards to recommendations specific to HRM, the community pharmacists should first become familiar with the list of medications that CMS considers to be high-risk (see Table 3). Pharmacists must be familiar with alternative therapy options to high-risk medications that are patient-specific solutions. Each time the pharmacist verifies or performs a quality assurance check on a prescription order, the pharmacist should review the order for any usage of high-risk medications. The patient profile should be reviewed for age to use during this assessment. There may be technological tools available through the prescription processing system, such as Drug Utilization Review, or DUR, alerts specific to HRMs. Additionally, for third-party prescriptions, some health plans have restrictions to use of an HRM, such as step therapy or prior authorization. The goal of the pharmacist should be to utilize all available methods, whether technology-based or manual, to catch and review HRM in patients ages 65 years and older. These are potential opportunities to impact the eventual receipt of that prescription by the patient. Pharmacies that are able to demonstrate they can help improve Star ratings may be able to gain a competitive advantage. PHARMACY QUALITY ALLIANCE ENDORSED PERFORMANCE MEASURES CMS rates the quality of Medicare 1 OCTOBER

2 Advantage plans using a scale of one to five stars, with five stars being the highest quality rating. The star ratings are created from various sets of performance measures. The Pharmacy Quality Alliance, or PQA, is a consensus-based nonprofit alliance with more than 100 member organizations that contributes to the development and review of medication-related measures. Currently, there are four PQA-endorsed medication-related measures being used by CMS toward the calculation of a plan s Star rating (see Table 1). Each measure is tripleweighted toward the overall Star rating. As of 2012, Medicare Advantage plans are eligible for quality bonus payments based upon their Star ratings. The current HRM measure was adapted from a previous Healthcare Effectiveness Data and Information Set, or HEDIS, measure and Drugs to be Avoided in the Elderly, or DAE, and identifies the percentage of adults ages 65 years and older who received two separate fills of a medication known to put the patient at high risk for an adverse drug event. 5 A select list of prescription drugs recommended to avoid in people ages 65 years and older by the American Geriatric Society Beers Criteria for Potentially Inappropriate Medications Use in Older Adults are considered to be high-risk medications for the HRM measure. The HRM rate is calculated using data from prescription drug events, or PDEs, over a calendar year. Any patient who will be 66 years of age or older on the last day of the measurement year and receives at least two prescription fills for the same high-risk medication during the measurement period is divided by the number of patients who will be 66 years of age or older on the last day of the measurement year. The lower the percentage of patients who fill a prescription for a high-risk medication, the better the rating for the plan. For 2015, the cut point for each star is shown in Table 2. 6 Because patients are not included in the HRM measure rate until they have a second prescription fill of a high-risk medication, there is great opportunity for community pharmacists to impact this measure after the first fill. Pharmacists can discuss the use of a high-risk medication with both the patient and the prescriber, and suggest alternatives to the prescriber to avoid future refills. Medicare Advantage plans may partner with community pharmacies to improve their Star ratings, especially in regards to the PQA-endorsed medication measures. Aside from pharmacies obtaining data through internal reports, some plans may provide HRM data directly to the pharmacy or through a Pharmacy Services Administration Organization, or PSAO. Table 1 PQA-endorsed medication-related measures utilized by CMS for Star rating calculations MEASURE DESCRIPTION CALCULATION High risk medication (HRM) Medication adherence to diabetes medications Medication adherence for hypertension (renin angiotensin system (RAS) antagonists) Medication adherence for cholesterol (statins) The percentage of Medicare beneficiaries ages 65 years or older who received two or more prescription fills of at least one drug with a high risk of serious side effects in the elderly The percentage of patients ages 18 years or older who adhere to their prescribed drug therapy across the following classes of diabetes medications: biguanides, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, incretin mimetics, meglitinides and SGLT2 inhibitors The percentage of Medicare Part D beneficiaries ages 18 years or older who adhere to their prescribed RAS antagonists: ACE inhibitors, ARBs or direct renin inhibitors The percentage of Medicare Part D beneficiaries ages 18 years or older who adhere to their prescribed drug therapy for statin cholesterol medications 1 Exclusion criteria: Patients who have one or more prescriptions for insulin in the measurement period and patients with ESRD 2 Exclusion criteria: Patients with ESRD Source: Acumen 2014 (see reference 7) Table 2 Star ratings categorical ranking by percent usage of HRM Another way pharmacies can receive HRM data is through a quality improvement organization, such as EQuIPP ( org). Community pharmacists may be positioned to have more direct impact with their patients and local prescribers than the health plan, which can help the health plan improve overall ratings. ADDRESSING HIGH RISK MEDICATIONS The Beers Criteria for Potentially Inappropriate Medication Use in Older Adults is designed by the American Geriatric Society to reduce exposure to medications that could potentially be harmful in the geriatric Numerator: Number of member years of enrolled beneficiaries ages 65 years or older with at least two fills of the same HRM Denominator: Number of member years of enrolled beneficiaries ages 65 years or older Numerator: Number of member years of beneficiaries ages 18 years or older enrolled during the measurement period with a proportion of days covered, or PDC, at 80% or more across the classes of diabetes medications. The PDC is the percentage of days in the measurement period covered by prescription claims for the same medication or another in its therapeutic category. Denominator: Number of member years of beneficiaries ages 18 years or older enrolled during the measurement period with at least two fills of medication(s) across any of the seven drug classes of diabetes drugs 1 Numerator: Number of member years of beneficiaries ages 18 years or older enrolled during the measurement period with a PDC at 80% or more for RAS antagonists Denominator: Number of member years of beneficiaries ages 18 years or older enrolled during the measurement period with at least two fills of any RAS antagonist 2 Numerator: Number of member years of beneficiaries ages 18 years or older enrolled during the measurement period with a PDC at 80% or more for statin cholesterol medications Denominator: Number of member years of beneficiaries ages 18 years or older enrolled during the measurement period with at least two fills of any statin medication PLAN TYPE 1 STAR 2 STAR 3 STAR 4 STAR 5 STAR MA-PD > 17% > 13% to 17% > 9% to 13% > 7% to 9% 7% PDP > 16% > 14% to 16% > 11% to 14% > 6% to 11% 6% population. As such, the criteria should be used as a guide for the pharmacist in selecting appropriate medication therapy. Table 3 is a summary provided by PQA of the HRM by class. If the need for a particular medication is present, use of agents from this list should be justified according to the indication for use and tolerability by the patient. This section will review some of those categories and provide suggestions and guidance for recommending alternative therapies when appropriate. Anticholinergics (excluding TCAs) First-generation antihistamines possess OCTOBER

3 Table 3 PQA High-Risk Medications summary DESCRIPTION ANTICHOLINERGICS (EXCLUDES TCAS) First-generation antihistamines (as single agent or as part of combination products) excludes OTC products Printed with permission from PQA *Infrequently used drugs. Abbreviations: TCAs, tricyclic antidepressants; OTC, over the counter. Note (in general unless otherwise specifed): Includes combination products and the following routes of administration: oral, transdermal, injectable (IJ, SC, IM, IV), rectal, sublingual, buccal and inhalation. ** Conjugated estrogen, esterified estrogen, estradiol, estropipate (includes combination products and the following routes of administration: oral and transdermal). ***Includes oral and injectable (IJ, SC, IM, IV) routes only. strong anticholinergic properties leading to higher risk of confusion, dry mouth and constipation in the elderly population. The strength of evidence supporting avoidance of this class is high for hydroxyzine and promethazine and moderate for all other agents. PRESCRIPTION PRODUCTS Brompheniramine Carbinoxamine Chlorpheniramine Clemastine When addressing use of these agents and making alternative recommendations, it is important to consider the indication for use. Second-generation antihistamines, such as loratadine or fexofenadine, are appropriate alternatives and preferred for seasonal or perennial allergies. Any Cyproheptadine Dexbrompheniramine Dexchlorpheniramine Diphenhydramine (oral) Doxylamine Hydroxyzine Promethazine Triprolidine Antiparkinson agents Benztropine (oral) Trihexyphenidyl ANTITHROMBOTICS Antithrombotics Ticlopidine* Dipyridamole, oral short-acting* (does not apply to the extended-release combination with aspirin) ANTI-INFECTIVE Anti-infective Nitrofurantoin (include when cumulative day supply is >90 days) (A) CARDIOVASCULAR Alpha blockers, central Guanfacine* Methyldopa* Reserpine (>0.1mg/day)* (B) Cardiovascular, other Disopyramide* Digoxin (>0.125mg/day) (C) Nifedipine, immediate release* CENTRAL NERVOUS SYSTEM Tertiary TCAs (as a single agent or as part of a combination product) Amitriptyline Clomipramine Antipsychotics, first-generation (conventional) Thioridazine Barbiturates Amobarbital* Butabarbital* Butalbital Doxepin (>6mg/day) (D) Imipramine Central Nervous System, other Chloral hydrate* Meprobamate Trimipramine Pentobarbital* Phenobarbital Secobarbital* Nonbenzodiazepine hypnotics (include when cumulative day supply is >90 days) (E) Eszopiclone Zolpidem Zaleplon Vasodilators for dementia Ergoloid mesylates Isoxsuprine ENDOCRINE Endocrine Desiccated thyroid Estrogens** with or without progesterone (oral and topical patch Sulfonylureas, long-duration Chlorpropamide Glyburide GASTROINTESTINAL Gastrointestinal Trimethobenzamide PAIN MEDICATIONS Pain Medications Meperidine Pentazocine* Non-COX-selective NSAIDS*** Indomethacin Ketorolac SKELETAL MUSCLE RELAXANTS Skeletal muscle relaxants (as a single agent or as part of a combination product) Carisoprodol Chlorzoxazone Cyclobenzaprine Metaxalone Megestrol Methocarbamol Orphenadrine antihistamine used as a hypnotic leads to tolerance and hangover sedation, which is associated with higher risk for falls. Alternative options for insomnia focus on sleep hygiene and occasional use of safer agents, such as trazodone or low-dose doxepin. 8,9 Such special situations as treat- 3 OCTOBER

4 ing a severe allergic reaction would still favor use of diphenhydramine, even in this age population. Antiparkinson agents benztropine and trihexyphenidyl historically have been used to treat tremors associated with Parkinson s disease. They are not recommended for prevention of antipsychoticinduced extrapyramidal effects; however, use of injectable benztropine is appropriate for reversal of dystonic reactions secondary to antipsychotics. 10 Such alternatives as dopamine agonists and carbidopa/levodopa are preferred treatments for Parkinson s disease. Antispasmodics are known to have high anticholinergic properties, and the efficacy of these agents is questioned. In general, one should avoid use of these. Exceptions include palliative care situations where such agents as scopolamine may be used to help treat copious oral secretions. Providing alternative recommendations for antispasmodics would require further investigation of the symptoms one desires to manage and the potential etiology for these symptoms. Antithrombotics Use of short-acting dipyridamole is associated with orthostatic hypotension and dizziness with moderate strength of evidence to avoid use. These criteria do not apply to the extended-release form in combination with aspirin for secondary prevention of stroke or TIA. Intravenous use of dipyridamole as part of cardiac stress testing is considered appropriate; however, use has declined in favor of adenosine. Ticolpidine carries a black box warning for potentially life-threatening hematologic reactions including agranulocytosis and thrombotic thrombocytopenic purpura, which requires routine laboratory monitoring. Clopidogrel is a newer and safer option with similar indications for use. Other agents, such as ticagrelor and prasugrel, are limited in their indications and would not be considered appropriate alternatives to ticlopidine. Anti-infective Nitrofurantoin Nitrofurantoin carries a risk of pulmonary toxicity and should be avoided for long-term suppression. In addition, the benefit of nitrofurantoin for treating urinary tract infections requires adequate renal function to achieve appropriate concentrations in the bladder. At present, recommendations are to avoid nitrofurantoin when CrCl is less than 60 ml/ min for concern of inadequate concentration in the urine and avoid long-term use (defined as >90 days) as suppressive therapy. Alternative recommendations for urinary tract infections depend on many factors, such as catheter-associated urinary tract infection, presence or absence of symptoms, severity of infection, urine culture and allergies. 11 Commonly used antibiotics may include renally eliminated fluoroquinolones or sulfamethoxazole/ trimethoprim. 12 Screening and treatment of asymptomatic bacteriuria is not recommended in this population. 13 Cardiovascular Alpha1-blockers have a high risk for orthostatic hypotension especially with initiation of therapy. Routine use as antihypertensives is not recommended given the higher risk of developing heart failure from alpha1-blockers compared with other antihypertensives. 14 Central-acting alpha agonists carry a high risk for adverse CNS effects including sedation, dizziness and headache. Although the evidence criteria supporting avoidance of these agents is low, it is suggested to avoid clonidine as a first-line antihypertensive in the geriatric population. Dosing limitations are placed on reserpine to avoid > 0.1 mg per day to minimize associated risk for depression. When making recommendations for the treatment of hypertension in the elderly, it is important to consider the desired goal blood pressure, and minimize risks of hypotension. Preferred agents would include thiazide diuretics, calcium-channel blockers, ACE inhibitor, and angiotensin receptor blockers. 15 Thiazide diuretics and calcium-channel blockers would be preferred for isolated systolic hypotension. Use of alpha1-blockers for treating symptoms of benign prostatic hyperplasia may be acceptable; however, the risk of orthostatic hypotension remains a concern. Newer agents, such as tamsulosin, alfuzosin and sildosin, are preferred for this indication. 16 Antiarrhythmic medications including class Ia, Ic and III should be avoided as first-line treatment for atrial fibrillation with high quality of evidence supporting this recommendation. Studies addressing rate versus rhythm control suggest that rate control provides a better and safer approach as first-line treatment for atrial fibrillation. 17 Amiodarone in particular is associated with multiple toxicities, including thyroid abnormalities, pulmonary fibrosis and potential for QT-prolongation. Disopyramide should be avoided because of negative inotropic effects and the risk of heart failure in older patients. In addition, disopyramide possesses strong anticholinergic properties. Dronedarone should be avoided in patients with permanent atrial fibrillation or those with systolic heart failure. Recommendations for alternative therapy will be determined by tolerability and efficacy. Not all individuals on antiarrhythmics require discontinuation. Some patients fare better with rhythm control, whereas others favor rate control. Assessing response to therapy, monitoring for adverse effects and consideration of comorbid conditions help to determine appropriateness of therapy. Digoxin doses > mg per day should generally be avoided in systolic heart failure. Higher doses have not been shown to give additional benefit and may increase the risks for digoxin toxicity. The risk for toxicity increases in those ages 70 years and older, those with impaired renal function and those with low, lean body mass. 18 Higher doses have been used for managing rate control in atrial fibrillation; however, other agents, such as betablockers or nondihydropyridine calcium channel blockers, are preferred as first-line agents for this indication. 19 Nifedipine immediate-release should be avoided for hypertensive urgency/emergency with high-quality evidence supporting this recommendation. Although effective, immediate-release nifedipine has the potential to produce sudden uncontrolled and severe reductions in blood pressure leading to ischemic events. 20 Alternative recommendations depend on the setting and route of administration. It is suggested to use agents that allow controlled reduction of blood pressure to avoid abrupt reductions. 21 Spironolactone in doses greater than 25 mg per day should be avoided in systolic heart failure and those with CrCl <30 ml/ min due to higher risk of hyperkalemia in the geriatric population. The risk for hyperkalemia is increased if using with ACE inhibitors, angiotensin receptor blockers, NSAIDs or potassium supplements. Central nervous system Tertiary tricyclic antidepressants, either alone or in combination, should generally be avoided due to their high anticholinergic properties, sedating effects and risk for orthostatic hypotension. The quality of evidence supporting this recommendation is high. Use of tricyclic antidepressants for treating depression has declined with preference to newer and safer medications, such as selective serotonin reuptake inhibitors or serotonin/norepinephrine reuptake inhibitors. 22,23 Such secondary amines as nortriptyline would be preferred over tertiary amines for treating neuropathic pain in the geriatric population due to less adverse effects.24 Dosing for neuropathic pain is lower than the recommended range for depression. Doxepin is considered safe OCTOBER

5 to use for insomnia if dosages are limited to 6 mg and under which correlates to a commercially manufactured product. Antipsychotics including first- and second-generation agents are associated with increased risk for stroke and higher mortality when used for controlling behavioral problems in patients with dementia. Use of antipsychotics for this purpose should be limited to those who have failed nonpharmacologic options or for patients who pose a threat to themselves or others. Alternative recommendations to antipsychotics would focus on nonpharmacologic therapies, including music therapy, massage therapy and person-centered communication skills for caregivers. 25 Pharmacotherapy for managing mild to moderate behavioral symptoms, particularly in those with Lewy Body Dementia, may include the anti-dementia agents donepezil or rivastigmine. 26 Such mood stabilizers as valproic acid may be used; however, the overall benefit is uncertain. 27 An additional concern exists for thioridazine and mesoridazine, since they possess anticholinergic properties and have a risk for QT prolongation. Barbiturates are known to have a high rate of physical dependence and should be avoided based on high level of supporting evidence. The majority of this class is rarely used; however, butalbital and phenobarbital use may be seen. Alternatives to butalbital for helping to abort headaches would likely be such agents as triptans or NSAIDs, depending on the type of headache, severity and presence or absence of comorbid conditions. Phenobarbital is an effective antiepileptic; however, newer agents are preferred. If a patient is stable on phenobarbital without seizure activity, there may not be a reason to change or discontinue. Benzodiazepines generally should be avoided for treatment of insomnia, agitation or delirium based on high supporting evidence. Older adults are more sensitive to their effects and at higher risks for cognitive impairment, delirium, falls, fractures and motor vehicle accidents secondary to use. Appropriate use in this age population would include aborting seizures, prevention of benzodiazepine or alcohol withdrawal, generalized anxiety and for symptom management in end-of-life care. Recommendations for alternatives to benzodiazepines will depend on the indication. In general, long-acting agents place patients at higher risk for adverse effects and should be avoided. Chloral hydrate and meprobamate are rarely used agents and generally not recommended in the geriatric population. Choral hydrate has a high risk for overdose, and tolerance develops to the sedative effect within days. Alternatives for insomnia have been listed elsewhere. Meprobamate has a high risk for physical dependence and should be avoided. Use of nonbenzodiazepine hypnotics eszopiclone, zolpidem and zaleplon for insomnia should be limited to fewer than 90 days. These benzodiazepine receptor agonists have similar adverse effects as the benzodiazepines in older individuals. They also have been linked with sleep-eating and sleep-driving. 28 Dosing limitations need to be considered, especially for zolpidem, as the maximum daily doses for women were changed recently. Ergot mesylates and isoxuprine lack evidence to support their use and should be avoided based on high level of evidence. At present, there are no effective alternatives. Endocrine Androgens, including testosterone, should generally be avoided unless there is an indication for moderate to severe hypogonadism in males. These agents carry a potential risk for cardiac problems and are contraindicated in men with prostate cancer. Desiccated thyroid preparations carry concerns about adverse cardiac effects. It is generally recommended to avoid these products in preference for such synthetic thyroid replacement as levothyroxine. Any change in thyroid supplementation should have repeat thyroid studies in four to six weeks. Estrogens with or without progestins have been shown to lack cardioprotective effect and cognitive protection in older women. There also is concern for breast and endometrial carcinogenic potential and higher risk for venous thromboembolism. Use of oral or topical patch should be avoided based on strong evidence. Topical low-dose intravaginal estrogens are acceptable for managing dyspareunia, prevention of lower urinary tract infections and other vaginal symptoms. Growth hormone should be avoided except as hormone replacement after removal of the pituitary gland. Sliding scale insulin should be avoided regardless of care setting. Risks for hypoglycemia are higher, and overall improvement in hyperglycemia management is not evident. Alternatives should consider blood-glucose goals in this population with the primary objective of avoiding hypoglycemia. Reasonable A1C goals for those living in long-term care or having end-stage chronic illness is less than 8.5%. 29 If insulin is required, use of basal insulin is preferred. An optional correction dose may be added based on patient sensitivity to insulin and blood-glucose goals. Megestrol has minimal effect on weight and an increased risk of thrombotic effect in older individuals, thus use should be avoided. Alternative options should focus on appetite stimulation and not weight gain. Possibilities may include low-dose mirtazapine or low-dose TCA. Other options, such as dronabinol or cyproheptadine, may be considered. 30 Long-acting sulfonylureas including chlorpropamide and glyburide have strong supporting evidence for avoidance in the geriatric population. Both agents have the potential to cause prolonged hypoglycemia with higher risks in frail older individuals and those with poor oral intake. Alternative sulfonylureas with less likelihood of hypoglycemia would include glimepiride and glipizide. 31 As with insulin, the overall blood-glucose goals would aid in determining the best treatment options for patients. Gastrointestinal Metoclopramide can cause extrapyramidal side effects, or EPS, which may be of greater risk in the geriatric population. Use as a prokinetic agent for gastroparesis is acceptable; however, lower doses (5 mg) are recommended to reduce risks for EPS. Alternative agents for nausea should target the likely etiology and may include use of such dopamine antagonists as prochlorperazine, or such serotonin antagonists as ondansetron. 32 Oral use of mineral oil should be avoided due to risks of aspiration and lipoid pneumonia. Alternative agents for constipation that are safe and well tolerated in the geriatric population include senna and low-dose polyethylene glycol. 33 Pain medications Meperidine has strong supporting evidence to avoid use in the geriatric population. It lacks efficacy in the oral formulation, and accumulation of metabolites can lead to neurotoxicity and seizures, especially in those with chronic kidney disease. 34 Such alternative agents as morphine, hydrocodone, oxycodone and fentanyl are better options if opioids are needed. 35 Non-selective NSAIDs carry an increased risk for gastrointestinal bleeding and peptic ulcer disease. High-risk groups would include patients older than 75 years of age or those with concurrent use of corticosteroids, anticoagulants or antiplatelet agents. It is recommended to avoid chronic use of NSAIDs unless other alternatives are not effective. Indomethacin and ketorolac have a higher risk for GI bleeding and peptic ulcer disease and should be avoided in the geriatric popu- 5 OCTOBER

6 lation. For gastrointestinal protection, use of a proton pump inhibitor or misoprostil is suggested. 34 Although the potential for ulcer development is not eliminated, risk will be reduced. Skeletal muscle relaxants are generally avoided due to poor tolerability. They possess strong anticholinergic properties, are sedating, increase the risk for falls and fractures and the efficacy at tolerated doses is questioned in this population. Alternative options may include such non-pharmacologic therapies as exercise, massage therapy and pain control. 36 Community pharmacists must focus on reducing and/or eliminating the use of HRMs in their patients. Pharmacists can make a big impact on patient outcomes and Star ratings by collaborating with the prescribers and patients to ensure medications are changed to safer alternatives. In addition to familiarizing oneself with the list of HRM and safer recommendations, communication skills should be honed to maximize successful recommendations. RECOMMENDING ALTERNATIVES TO HIGH- RISK MEDICATIONS Communicating with patients Effective communication between pharmacists and patients is an important part of improving patient satisfaction, medication adherence and health outcomes. 37 Educating patients about their medical conditions and medications allows patients to take a role in their own health care. This aligns with the patient-centered care movement. Community pharmacists communicate with patients about insurance formulary issues and co-pay concerns on a daily basis. Upon identification of a high-risk medication either as a new prescription or during a retrospective drug utilization review, the first step is to talk with the patient to determine what they already know. This conversation could be conducted using patient friendly lay language rather than medical terminology. The pharmacist should assess the patient s current knowledge by asking questions related to the patient s needs, concerns, readiness to learn, preferences, support and barriers and limitations. 38 To determine the appropriateness of the medication a discussion about the indication and length of therapy the patient is anticipating should occur. If the medication is chronic, alternative medications should be suggested. It also is important to ask about previous medications the patient has tried for this symptom or condition. If a previous medication was safe and Table 4 Steps for verbal recommendations STEPS 1. Introduce yourself and provide your contact information. 2. Identify the patient using full name and date of birth. 3. Provide a brief summary of the pharmacist-patient encounter. 4. Clearly and concisely state the drug-related problem. 5. Provide a recommendation to solve the drug-related problem. 6. Provide evidence to support the recommendation. 7. Conclude by offering assistance with further questions or follow-up. Table 5 Steps for written recommendations effective, it would be appropriate to recommend that medication again. The pharmacist should address any concerns the patient has related to changing therapies, such as adverse effects, drug interactions and cost. To provide closure to the conversation, the pharmacist should utilize the teach-back technique to confirm the information has been explained in a way the patient can understand and offer a plan for the next steps. Communicating with prescribers Outside of taking new prescriptions, community pharmacists often have limited and sporadic contact with prescribers. In addition, when pharmacists initiate communication with prescribers, it usually is reactive in nature. For example, the pharmacist is contacting the prescriber to inform them of a drug-related problem (i.e., allergy to a medication, incorrect dose of a medication, previous adverse effect, insurance company formulary issue or medication is too expensive concern). 39 When pharmacists seem to only be pointing out problems or prescribing errors, prescribers interpret and receive a negative message, although unintended. Often, communication with prescribers is handled by such intermediaries as nurses, receptionists or other office staff. The intermediaries may STEPS 1. Introduce yourself and provide a brief description of the pharmacy service (i.e., MTM). 2. Identify the patient using full name and date of birth. 3. Provide a brief summary of the pharmacist-patient encounter. 4. Provide a patient-specific medication list (optional). 5. Clearly and concisely state the drug-related problem. 6. Provide a recommendation to solve the drug-related problem. 7. Provide evidence to support the recommendation. 8. Offer assistance with further questions or follow-up. 9. Conclude by providing your contact information. 10. Include a copy of the SOAP note related to the pharmacist-patient encounter (optional). 11. Limit the written communication to one page, if possible. or may not have formal training in health care. These barriers do not allow for opportunities for collaborating or establishing mutually respectful professional relationships. 39,40 Community pharmacists have a duty to contact prescribers when concerns about patient-specific contraindications, drug interactions, adverse effects or medication safety issues arise. Methods of communicating with prescribers include verbal communication (in-person or telephone), written notes in the electronic health record (EHR), business letters, handwritten notes, faxes or . To enhance the likelihood that the recommendation will be accepted by the prescriber, the pharmacist should use assertive communication strategies to concisely describe the problem and provide an evidence-based solution. See Tables 4 and 5 for templates for verbal and written recommendations, respectively. Effective communication ensures the patient receives safe high-quality care. Assertive communication is a skill. Being assertive means that the pharmacist expresses himself or herself effectively and stands-up for the patient while respecting the knowledge and responsibilities of the prescriber. It is important to be assertive in what is said, as well as how the recommendation is delivered. Being OCTOBER

7 PATIENT SCENARIO 1 Mr. Chapman is a 67-year-old male who presents to the in-window of the community pharmacy with a new prescription for cyclobenzaprine (Flexeril ) 10 mg. The directions are to take 1 tablet by mouth three times daily as need for pain #45. He explains that he recently pulled a muscle in his back while working in the yard. Upon review of his profile it is noted that he takes lisinopril 20 mg by mouth daily, atorvastatin 40 mg by mouth every night at bedtime and multiple vitamin by mouth daily. Perform a prospective drug utilization review and complete the following: 1. Identify which medication(s) from his list is/are classified as a high-risk medication. 2. Provide a rationale, using evidence-based medicine, for why he should avoid this medication. 3. Provide the rationale in patient-friendly lay language to describe the concern to Mr. Chapman. Discussion 1. Cyclobenzaprine (Flexeril ) is the only medication from Mr. Chapman s list that is considered a HRM. 2. Cyclobenzaprine is a skeletal muscle relaxant, which is identified on the Beer s List and Centers for Medicare and Medicaid Services list of high-risk medications for elderly patients. Use of this medication has been associated with an increased risk of anticholinergic adverse effects dry mouth, dry eyes, urinary retention and constipation as well as sedation, cognitive impairment, weakness and confusion. Other medications, such as baclofen or tizanidine are available that could offer relief of the muscle pain without the adverse effects. 3. A conversation between the pharmacist and the patient could follow this style: Mr. Chapman, I would like to talk to you about the new prescription for cyclobenzaprine (Flexeril) you brought in today. This medicine has the potential to cause a lot of side effects. The benefit the medicine may have might not be worth the side effects. There are two other medicines available that can help with muscle pain that should not have as many side effects. Since this is a new prescription for you and you have not tried any other muscle pain relievers before, I recommend we call your doctor to see if you could try one of the other medicines with fewer side effects first. PRACTICE POINTS 1. The use of High Risk Medications by enrollees is a factor in a Medicare Advantage plan s Star ratings from the Centers for Medicare and Medicaid Services. 2. Community pharmacists can help improve a Medicare Advantage plan s Star ratings by working with the plan to reduce patient s use of high-risk medications. 3. The Beers Criteria should serve as a guide for potentially inappropriate medications. The decision to eliminate or change a medication should be on an individual patient basis. 4. The overall goal is to reduce the use of inappropriate medications. In doing this, one must consider the physiologic age of the individual and the indication for the medication, as well as the presence of comorbid conditions or other medications that can negatively impact the patient. 5. All recommendations for medication management to prescribers should be justified through the use of evidence-based medicine. assertive can help pharmacists earn the respect of prescribers. Passive communication sends a message of unimportance and allows others to disregard the recommendation. Aggressive communication sends a message of bullying and intimidation while making the pharmacist appear self-righteous or superior. This may lead to opposition from prescriber, even if the recommendation is appropriate. Before sending a recommendation to a prescriber, consider the language used to relay the strength of the recommendation. Please consider, I recommend, I highly recommend and I strongly advise indicate low-, medium- and high-level strengths of recommendations, respectively. An aggressive or too strong of a recommendation from a pharmacist may insinuate the prescriber has committed an error and open them up to liability. Pharmacists need to be aware of the tone implied with the recommendation and not make prescribers look incompetent. Conciseness also is a skill to develop to assist with successful recommendations. It is important to briefly state why the problem is pertinent to the patient and the prescriber. The number of details pharmacists want to provide to a prescriber to justify their recommendation may be overwhelming. This often leads to the delivery of extraneous information, prescriber confusion and ultimately the prescriber denying the recommendation. A pneumonic commonly found in the nursing literature that provides a structured framework to concisely organize information prior to contacting prescribers is Situation, Background, Assessment and Recommendation, or SBAR 41 Utilizing a procedure like SBAR to address issues succinctly and thoroughly helps to facilitate communication. 42 The SBAR technique has been shown to save time, reduce frustration and improve overall communication between healthcare providers. 40 Template forms are another way to provide information concisely. A study by Johnson et al dealing with medication adherence communication with prescribers, found that they preferred simpler forms that utilized vertical columns to flow in the direction one reads to decrease information overload. 43 Adding check boxes to allow the prescriber to select the recommendation they prefer, along with signature lines, can turn the form into a new prescription if needed. CONCLUSION Community pharmacists are great at identifying drug-related problems but often feel uncomfortable making patientspecific recommendations to prescribers. For example, a pharmacist receives an insurance adjudication rejection stating that a drug is not covered. The pharmacist calls or faxes the rejection to the prescriber and waits for a response. This sends an unspoken message that the prescriber made a mistake, and now the pharmacist wants to know what the prescriber intends to do about it. Suggesting a solution in a professional manner builds a trusting professional relationship and allows for recognition of the pharmacists skills as the medication expert. In addition to providing a solution, all recommendations should be justified through the use of evidence-based medicine. Recommendations should be guideline-driven using the most current edition, and include citations for references. For high-risk medications, recommendations should include how the medication could potentially harm or has harmed the patient, along with a journal article or guideline reference from the literature. Including potential or actual adverse effects experienced by the patient as a result of the medication helps to strengthen the recommendation to change pharmacotherapy. Recommendations that are patient and drug-specific that include where the information was obtained are more likely to be accepted by providers. 7 OCTOBER

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To submit answers, visit our website at Please note: Assessment questions submitted online will appear in random order. 1. Community pharmacists can help MA-PD plans achieve lower HRM rates, and potentially higher Star ratings, through which of the following method(s)? (LO 1) a. Contacting prescribers to suggest alternatives for high-risk medications b. Providing sleep hygiene suggestions to patients c. Identifying high-risk medications being used by patients d. All of the above 2. Which of the following MA-PD enrollees would be counted in the numerator of that plan s HRM rate measure for the previous calendar year? (LO 1) a. 64-year-old female who filled a butalbital/acetaminophen/caffeine prescription three times for migraine b. 67-year-old male who received a prescription for glyburide each month c. 70-year-old female who filled a onetime prescription for zolpidem d. All of the above 3. Each PQA-endorsed medication measure carries a weight for a Medicare Advantage Plan s CMS Star ratings. (LO 1) a. Single b. Double c. Triple d. Quadruple 4. Individual pharmacies are uniquely positioned to be able to help improve Medicare Advantage plan Star ratings. (LO 1) a. True b. False OCTOBER