Pharmacy E-News February 2018

Transcription

1 In this issue: Association between initial opioid use and the likelihood of becoming a longterm opioid user The beta agonist paradox HEDIS new measure updates for 2018 Commercial pharmacy benefit updates for 2018 FDA medication alerts for 2018 References Pharmacy News is produced quarterly for contracted network clinicians and is published under Pharmacy Web pages on MyGroupHealth for Providers. Access the site on onehealthport.com or at kp.org/wa/provider. Feel free to share the newsletter with colleagues. If you would like to be notified when the newsletter is published, or for more information about the articles, contact a Kaiser Permanente Clinical Pharmacist at or e mail: goertzen.g@ghc.org. Association between initial opioid use and the likelihood of becoming a long-term opioid user By Hoa Tang, Pharmacy Intern; Reviewed by Beth Arnold, PharmD, BCPP & Krystal Ngo, PharmD Key points To prevent long-term opioid use, the Centers for Disease Control & Prevention (CDC) guidelines recommend prescribing opioids for preferably less than three days and no more than seven days for the treatment of acute pain. The likelihood of chronic opioid use increases with each additional day of medication supplied starting with the third day. The probability of chronic opioid use increases greatly after the fifth and thirty-first day of therapy, when the patient receives a third prescription or refill, or an initial 10- or 30-day supply. Study methodology In the CDC s Morbidity and Mortality Weekly Report (MMWR), a study of 1.3 million patient records recorded between June 1, 2006 and September 1, 2015, were analyzed for signs and characteristics of long-term opioid use. Patients in this study were 18 years of age and older and were opioid naïve. Opioid naïve was defined as at least 6 months without an opioid prescription prior to the first opioid prescription. Patients were followed until the end of study or until discontinuation of opioids defined as at least 180 days without opioid use. First opioid prescriptions were categorized into different groups, which included long-acting, oxycodone short-acting, hydrocodone short-acting, other DEA schedule-ii(cii) short-acting, C-III- IV, nalbuphine, and tramadol. 1

2 The study explored the correlation between: duration of treatment, number of prescriptions, cumulative morphine equivalent dose (MED), the number of days supply, choice of first opioid prescription, and probability of continued opioid use at one and three years. Characteristics of initial prescription episodes and long-term opioid use The largest incremental increase in probability of long-term opioid use was observed when the first prescription days supply exceeded 10 or 30 days, when patient received a third opioid prescription, or when the cumulative dose was greater than 700 mg MED (Figure 1 & Figure 2). Patients initiated on long-acting opioids as the first opioid prescription have the highest probability of long-term opioid use whereas patients on short-acting opioid treatments have a lower probability of long-term opioid use at one and three years as seen in Table 1. The probability of long-term opioid use was similar for all of the short acting opioids included in the analysis. Despite tramadol s better safety profile and lower abuse potential, it had the second highest probability of long-term opioid use at one and three years. o This may have been due to tramadol being prescribed intentionally for long-term use. o It is important to note that there is limited data on long-term use of tramadol, with only one trial exceeding 12 weeks in duration. Approximately one in seven persons were still on opioids a year later if they received a refill after their first opioid prescription. As days supply, number of prescriptions, or MED cumulative dose increases, the probability of long-term opioid use also increases. 2

3 Table 1. One- and three-year probabilities of continued use and median time to discontinuation of opioid use, by choice of first opioid prescription Choice of first prescription Number of patients, n (%) One-year probability of continued use, % Three-year probability of continued use, % Median days to discontinuation Long-Acting 6,588 (0.5) Opioids Tramadol 120,781 (9.33) Hydrocodone Short Acting Oxycodone Short Acting Schedule III Short Acting Schedule III-IV and Nalbuphine 742,122 (57.3) ,224 (16.9) ,877 (1.2) ,665 (14.7) Limitations Only the total cumulative dose was taken into consideration and not dose increases or decreases over time. Some factors that might influence the duration of opioid use, like pain intensity score or the etiology of pain were not considered in the analysis. Self-pay and illicit prescriptions were excluded in the analysis. Important considerations The study quantitatively shows there is a strong correlation between chronic opioid use and the initial prescription in the acute care setting. If opioids are not carefully initiated, they can cause more harm (overdose complications, opioid use disorders, withdrawals, addiction, cardiovascular and respiratory events, etc.) than benefits. For acute pain management, the CDC guidelines recommend treating with the lowest effective dose of short-acting opioids for a duration of three days or less to minimize chronic opioid use. When initiating opioids, it is important to consider: o The use of non-pharmacologic and non-opioid pharmacologic therapy before opioids. o Prescribing the shortest effective duration of therapy, preferably less than three days and no more than seven days. o Prescribing a low dose, preferably a MED of less than 90 mg/day and no more than 120 mg/day. KPWA safety guidelines for patients on chronic opioid therapy for chronic non-cancer pain have been adopted from the Washington State Agency Medical Directors Group recommendations. 3

4 The beta agonist paradox By Mark La Shell, MD, Program Chief, Allergy & Asthma Clinical questions Why is albuterol overuse dangerous? In 1989, a case-control study was published suggesting that an asthma mortality epidemic that had plagued New Zealand for more than a decade was due to fenoterol a short-acting beta agonist used to treat asthma. When this drug was pulled from the market shortly thereafter, asthma mortality in New Zealand markedly decreased. (Crane 1995) How could a medication used to treat the bronchospasm of asthma actually make asthma worse? The answer rests on two key facts: 1. In asthma, inflammation of the bronchial tubes (airway wall thickening and mucus production) results in airway obstruction. 2. Beta agonists such as albuterol are pro-inflammatory. Use of beta agonists has been associated with increased inflammatory markers including sputum inflammatory cells, and their overuse has been associated with increased airway hyper-responsiveness and impaired beta2-adrenergic receptor expression. There have been concerns about adverse effects from overuse ever since the advent of beta agonist treatments 50 years ago. After the New Zealand experience, asthma guidelines around the world were modified to recommend that patients use beta agonists "as needed" rather than on a regular schedule. Around the same time, more effective anti-inflammatory treatments namely, inhaled corticosteroids became available. Together, more limited use of beta agonists and more effective treatment of asthma's inflammatory component have helped reduce asthma mortality dramatically in the U.S. (Moorman 2007) and worldwide since the 1990s. With these improvements, however, the awareness of the risks of albuterol overuse has diminished, especially among patients. How much albuterol is too much? When used in moderation, albuterol is a safe, effective, and essential treatment for asthma. However, we now know that a patient's increasing use of albuterol reflects a lack of control of the inflammation that underlies the patient's asthma, and that the albuterol itself could be making this worse. 4

5 Recommendations There are three methods to help identify albuterol overuse: 1. The rule of two s. We often invoke the "rule of two s" to identify when a patient is at risk for albuterol overuse. If patients use albuterol more than twice a week (except for exercise) or their asthma wakes them up more than twice a month, their asthma is likely not well controlled. (Another possibility is that they may be overusing albuterol to treat a different condition, such as GERD, anxiety, or cough induced by post-nasal drainage.) 2. Albuterol refills. Every canister of albuterol contains 200 puffs. For the majority of wellcontrolled asthmatics, one canister a year is sufficient for good asthma control. More than two in a year should at least raise the question of whether the patient's asthma is well controlled or not. For more information, read the "200 Puffs Is Enough" clinician FAQ in the October 2017 Pharmacy News. 3. HEDIS. The HEDIS asthma medication ratio (AMR) measures asthma controller (antiinflammatory) use against albuterol use: Asthma Medication Ratio Individuals 5 85 years of age with persistent asthma who had a ratio of controller medication to total asthma medications of 0.50 or greater. (Note: In 2018, the age range will change to 5 65 years, which is forecast to lower overall performance.) When patients are overusing albuterol, their AMR will go below 0.5, as shown in a 2016 chart review of KPWA asthma patients as well as a published trial (Schatz 2010). Patients with AMR < 0.5 are at increased risk for asthma hospitalization and emergency department visits. At KPWA, patients in the and age groups have the most room for improvement in terms of albuterol overuse. How could this change my practice? When prescribing albuterol for patients with asthma, know that one canister with zero refills will suffice for most patients. See the "200 Puffs Is Enough" clinician FAQ in the October 2017 Pharmacy News. Remember the rule of two s when talking to patients about asthma, and always be wary of asthma mimics, even in patients with an established asthma diagnosis. See the recent Clinical Pearl, "Asthma diagnosis in four easy steps." Any time your patients need an albuterol refill, look to see how much they've used in the past year. If they've used more than one or two canisters (and it's not for exercise only or extra medication to keep at school, etc.) then it's time to intervene and help identify what is leading to so much albuterol use. 5

6 HEDIS new measure updates for 2018 By Rebecca West, Pharmacy Student; Edited by Katrina Zywiec, PharmD Key Points: The National Committee for Quality Assurance (NCQA) developed several new HEDIS quality measures around transitions of care, opioid/substance abuse use, and depression screening. Kaiser Permanente of Washington (KPWA) is currently developing clinical strategies to align with these measures and monitor progress. Providers can use these performance measures to ensure they are meeting current best practices when addressing care transitions, prescribing opioids, and performing preventative screening. Background HEDIS (Healthcare Effectiveness Data and Information Set) measures are developed by the National Committee for Quality Assurance (NCQA) annually. To develop quality measures, NCQA reviews available clinical guidelines and evidence to identify clinical areas with opportunity for improvement in cost effectiveness, efficiency, or quality of care. HEDIS measures allow for consistent tracking across health plans and help identify areas for improvement. Provider groups can use these standard health care performance measures to ensure they are providing the highest quality care consistent with other health plans and best practices. The tables below provide brief descriptions of the new 2018 measures. Description: The percentage of inpatient discharges for Medicare members 18 years old with the following: 1. Notification of inpatient admission Same day or day after admission Date and time stamp 2. Receipt of discharge information Same day or day after discharge 3. Patient engagement after discharge Within 30 days of discharge (not same day) 4. Medication reconciliation post-discharge Same day or within 30 days of discharge Reconciliation of discharge and outpatient meds by physician, pharmacist, or nurse Transitions of Care (TRC) Rationale: Approximately 80% of serious medical errors involve miscommunication during the hand-off between medical providers. Effective care transition can reduce readmission rates and adverse events. KPWA Strategy: Leverage software that identifies patients who register at an emergency facility within WA or OR state, collects discharge information, and risk-stratifies patients. Depending on risk, patient outreach and medication reconciliation are completed by clinical pharmacy or care management. 6

7 Follow-Up After Emergency Department (ED) Visit for People with High-Risk Multiple Chronic Conditions (FMC) Description: Percentage of ED visits with follow-up service within 7 days. This measure applies to Medicare members 18 years old with 2+ high-risk chronic conditions prior to ED visit. Chronic conditions: Chronic Obstructive Pulmonary Disease (COPD), asthma, Alzheimer s, chronic kidney disease, depression, heart failure, myocardial infarction, atrial fibrillation, stroke Rationale: ED discharge is another opportunity to provide effective care transition to reduce readmissions and adverse events. Patients with multiple chronic conditions are high risk for medication errors. KPWA Strategy: Software identifies patients and outreach is done by clinical pharmacy or care management. Use of Opioids at High Dosage (UOD) Description: The rate of members taking a high dosage of opioids for > 15 day supply. High dosage is defined by NCQA as total morphine equivalent dose (MED) > 120 mg. Opioids NOT included: Injectables, cough and cold products, buprenorphine products, Ionsys (fentanyl transdermal (TD) patch) Note: KPWA providers target a goal of MED < 90mg when prescribing, which aligns with CDC guidelines. Use of Opioids From Multiple Providers (UOP) Description: The rate of adult members who received opioids from multiple providers for > 15 day supply. Three rates are reported: Multiple Prescribers: The rate of members receiving prescriptions from 4+ prescribers Multiple Pharmacies: The rate of members receiving prescriptions from 4+ pharmacies Multiple Prescribers and Pharmacies: The rate of members with both Opioids NOT included: same as for UOD Rationale: High dosage, multiple prescribers, and multiple pharmacies are all risk factors for dangerous overdose and death. In a 2 year study, 55% of fatal overdose patients were receiving opioids from 3 pharmacies or prescribers and/or high dosage. KPWA Strategy: KPWA providers are monitoring chronic opioid users with a chronic opioid therapy plan and educating patients on the risks associated with opioid use. KPWA is currently developing strategies to provide coordinated multidisciplinary pain management and improve utilization monitoring. Depression Screenings and Follow-Up for Adolescents and Adults (DSF) Description: The percentage of members > 12 years old, screened for clinical depression using a standardized tool. Also, if the patient screened positive for clinical depression, they received follow-up care within 30 days. Standardized tools: Patient Health Questionnaire (PHQ)- 9, PHQ-2, etc. Follow-up care: Behavioral health encounter, outpatient visit, telephone visit, case manager visit, or dispensing of an antidepressant medication Rationale: The U.S. Preventative Services Task Force (USPSTF) recommends that all people age 18 and older, including pregnant and postpartum women, should be screened for depression. KPWA Strategy: KPWA clinics now have a standard screening process that includes PHQ-9. Clinical pharmacists complete a PHQ-2 during chronic disease management. Positively screened patients are followed by behavioral health or the primary care provider. 7

8 Unhealthy Alcohol Use Screening and Follow-up (ASF) Description: The percentage of all members 18 years old, who were screened for unhealthy alcohol use using a standardized tool. Also if the patient screened positive for unhealthy alcohol use, they received follow-up care within 2 months. Standardized tools: Alcohol Use Disorders Identification Test (AUDIT), AUDIT-C, etc. Acceptable follow-up care: counseling a minimum of 5-15 minutes including at least one of the following: feedback on alcohol use, identification of high risk situations and coping strategies, development of a plan, or documentation of alcohol misuse treatment Rationale: Alcohol misuse is a leading cause of illness, lost productivity, and preventable death in the U.S. KPWA Strategy: The standard screening implemented at all KPWA clinics includes questions regarding alcohol and substance abuse. Counseling for positively screened patients can be provided by the primary care provider or patients can be referred to an alcohol treatment program. KPWA is developing strategies to improve outpatient alcohol treatment services, with pharmacological interventions and care management. Conclusion: KPWA is continuously improving its clinical programs and patient care by aligning with standard best practices. Quality measures, such as HEDIS and Medicare Stars, allow for consistent tracking across health plans, help KPWA prioritize our strategy development, and help identify opportunities for improvement. Commercial Pharmacy Benefit Updates for 2018 By Barbara Arenz, PharmD, BCPS & Krystal Ngo, PharmD Key Points: Effective January 1, 2018, the following changes have occurred: o Kaiser Permanente Washington (KPWA) will now provide preventative care coverage of low to moderate potency statins at no cost for members 40 to 75 years of age enrolled in applicable plans. o Up to a 12-month supply of contraceptive drugs may be filled at once. o An opioid soft edit will trigger for Medicare and commercial members with cumulative Morphine Equivalent Dosing (MED) of >90. o Hard claim rejections for invalid DEA license scope of practice will trigger at point of sale. Changes are on the horizon for KPWA commercial members. These changes represent KPWA s continued efforts to offer high quality, safe, affordable health care in accordance with state and federal regulations. 8

9 Coverage of statins for primary prevention A new United States Preventative Services Task Force (USPSTF) Grade B recommendation endorses statin use for the primary prevention of cardiovascular disease. The USPSTF recommends that adults without a history of cardiovascular disease (CVD) use a low to moderate dose statin for the prevention of cardiovascular (CVD) events and mortality when all of the following criteria are met: o Age 40 to 75 years o One or more CVD risk factors (i.e., dyslipidemia, diabetes, hypertension, or smoking) o Calculated 10-year risk of a cardiovascular event of 10% or greater The Affordable Care Act and federal regulations require that drugs with USPSTF Grade A or Grade B preventative care recommendations be covered at no cost to members by most commercial plans. KPWA will provide preventative care coverage of low to moderate dose generic statin medications at no cost to members 40 to 75 years of age in applicable plans starting January 1, Maximum day supply extended for contraceptives A new Washington state law requires that health plans with contraceptive drug coverage allow members access to a 12-month supply at once. Since January 1, 2018, KPWA has allowed contraceptive drugs to be filled for up to a 12- month supply at once. Prescribers and members may still request receipt of a smaller supply. Federal Employee Health Benefit and self-funded plans are not subject to the new regulation. All preferred contraceptives except the etonogestrel/ethinyl estradiol vaginal ring (NuvaRing) will be eligible for an extended day supply. The NuvaRing label does not allow 12-month dispensing, since the product should not be stored for longer than four months. Non-preferred contraceptives are not automatically included in this regulation. If a member or provider requests and is granted an exception or contraceptive waiver, the contraceptive is eligible for a 12-month supply. Opioid Soft Edit In 2017, the Center for Medicare and Medicaid Services (CMS) mandated that all Medicare Part D sponsors implement a cumulative Morphine Equivalent Dosing (MED) edit at point of sale. This edit is intended to reduce risks of overdose due to high dose opioid use. A similar edit is also mandated by OptumRx, our pharmacy benefits manager (PBM). Effective 1/1/18, an opioid soft edit has been added for cumulative therapy MED thresholds >90 for Medicare and commercial members. 9

10 The soft edit was previously for a cumulative MED threshold of >100 for Medicare members. However, this threshold has been lowered for For Medicare Part D and commercial members, the soft edit will be triggered for patients obtaining a cumulative MED of >90. This edit is a soft edit which will require override by the pharmacy, but no further action is required at this time aside from following our opioid guidelines for patient safety. DEA Scope of Practice Check Effective 1/1/18, our PBM, OptumRx, is enabling an enhanced Drug Enforcement Agency (DEA) license scope of practice check at point of sale for all Schedule II-IV controlled medication claims to prevent payment for claims from unauthorized prescribers. Hard claim rejections due to DEA license scope of practice may result from the following: Prescriber s DEA is expired Prescriber s DEA is invalid or entered incorrectly Prescriber s DEA does not match the scheduled drug of the claim Hard rejections due to any of the reasons above cannot be overridden at point of sale by the pharmacy. The prescriber may contact the OptumRx Pharmacy Help Desk to request a data validation and update to their license records on file. FDA Medication Alerts Drug Safety Alert Link Febuxostat (Uloric ) Limbrel capsules FDA to Evaluate Increased Risk of Heart-Related Death Preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat compared to allopurinol. Once the final results from the manufacturer are received, the FDA will conduct a comprehensive review and will update the public with any new information. The febuxostat drug labels already carry a Warning and Precaution about cardiovascular events because the clinical trials conducted before approval showed a higher rate of heart-related problems in patients treated with febuxostat compared to allopurinol. Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems The FDA is investigating Limbrel, a product marketed as a medical food, due to reported adverse events, drug-induced liver injury and hypersensitivity pneumonitis. Consumers should stop taking immediately and contact their health care provider. Link Link 10

11 Varubi (rolapitant) Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions during or soon after infusion of Varubi (rolapitant) have been reported in the postmarketing setting, some requiring hospitalization. Healthcare professionals should be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi (rolapitant) injectable emulsion, both during and following administration. Link References: 1. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain - United States, JAMA. 2016;315(15): Shah A, Hayes CJ, Martin BC. Characteristic of Initial Prescription Episodes and Likelihood of Long-Term Opioid use United States, MMWR Morb Mortal Wkly Rep 2017;66: Crane J, Pearce N, Burgess C, Jackson R, Beasley R. End of New Zealand asthma epidemic. Lancet Apr 15;345(8955): Moorman JE, Rudd RA, Johnson CA, et al; Centers for Disease Control and Prevention (CDC). National surveillance for asthma-united States, MMWR Surveill Summ Oct 19;56(8): Schatz M, Zeiger RS, Yang SJ, et al. Relationship of asthma control to asthma exacerbations using surrogate markers within a managed care database. Am J Manag Care May;16(5): HEDIS 2018 Technical Specifications. Accessed 24 October Solet DJ, et al: Lost in translation: challenges and opportunities in physician-to-physician communication during patient hand-offs. Academic Medicine. 2005;80: Baumblatt, JA, Wiedeman, C, Dunn J, et al. High-Risk Use by Patients Prescribed Opioids for Pain and its Role in Overdose Deaths. JAMA Intern Med. 2014; 174(5): Siu, A. US Preventative Services Task Force (USPSTF). Screening for Depression in Adults. JAMA. 2016; 315(4): Center for Disease Control and Prevention. Preventing a Leading Risk for Death, Disease, and Injury. Retrieved from Accessed on January 17,