Jennifer Chen, PharmD, CGP
The FDA has withdrawn approvals for the use of niacin or fenofibrate in combination with statins for the treatment of high cholesterol. The FDA also withdrew approval of the indications related to the adjunctive therapy to a statin with niacin extended-release tablets (Niaspan) or fenofibrate delayed-release capsules (Trilipix). This decision directly impacts two medications, Advicor and Simcor, both contain niacin with a statin (lovastatin and simvastatin, respectively) and they are no longer on the market.
The FDA made this decision based on several large trials including AIM-HIGH, ACCORD and HPS2-THRIVE, which collectively showed no benefits of adjunctive therapy to statins for the reduction in the risk of cardiovascular events. According to the studies, further reduction of LDL cholesterol did not translate to the reduction of cardiovascular events. In the absence of benefits, serious adverse events such as myopathy were statistically significantly higher in patients taking niacin with statin.
Niacin and fenofibrate are still available individually on the market. While niacin is also available over-the-counter, patients medications should be reviewed and patients should be educated on efficacy concerns about combination therapy as the benefits of the drugs no longer outweigh the risks.
Preventive care, referring to medical interventions with anticipated long-term benefits, is often inappropriately continued near the end of life. Majority of patients, who were on cholesterol-lowering medications prior to starting hospice, remained on the therapy. This is a great opportunity for hospice care providers and patients to discuss the appropriateness of continuing preventive care as part of an important conversation about prognosis. As patients are often worried about the risks associated with discontinuation, recent studies have shown that the discontinuation of statin therapy in the setting of advanced illness is actually safe and may be associated with benefits. These benefits include improved quality of life, reduced pill burden and reduction in medication costs.
Our pharmacists have put together a patient directed letter to help you communicate with your patients regarding the discontinuation of cholesterol-lowering drugs. This letter can be found in the clinical resources section of member section.
Jenny Chau, RDH, PharmD
Hospice Pharmacy Solutions (HPS) and Outcome Resources (OR) have dedicated clinical pharmacists, who work with our hospice providers, to provide quality care to the hospice patients we serve. Many of the clinicians at the hospices we work with may not be aware that our clinical pharmacists provide a wide range of clinical support services and are available 24/7. This article will focus on some of the core, highly rated services that are valued by hospice providers. These clinical support services include: pharmacist medication reviews, pharmacists consultations, newsletters and blog articles, educational presentations and online clinical resources.
Pharmacist Medication Reviews
Comprehensive medication reviews provided by our clinical pharmacists exceed the standards of the Medicare Conditions of Participation (CoP). The medication review service helps many hospice providers to stay in compliance from patient being admitted to discharge. Medications were reviewed not only at admission, but also re-reviewed in accordance to each hospice interdisciplinary team (IDT) meetings depending on the hospices’ need. In each medication review, our clinical pharmacists make recommendations on coverage decisions, highlight any cost-effective therapeutic alternatives, identify clinically significant drug interactions, and point out any therapeutic duplications to help decrease cost and adverse effects. At the end of each medication review, a personalized summary of recommended action items is provided to help with disease and symptoms management. Our medication reviews are unique and highly rated for providing clear and concise recommendations for the Interdisciplinary Team (IDT) to help improve quality of patient care, reduce medication cost and stay compliance with CoP.
Pharmacist consultations are available 24/7 every day in the year. This is a great opportunity for nurses, physicians and pharmacists to collaborate and provide the best possible care to your patients. Our clinical pharmacists are here to help discuss any medication and/or symptom related topics relating to your patients. Common topics include: opioid dose conversion, pain and palliative symptom management, and general drug information (i.e. availability/formulation, therapeutic alternatives, cost and adverse effects).
Newsletters and Clinical Blogs
Our newsletter, The Clinician, and our clinical blog contain original hospice oriented articles that are prepared and chosen carefully by our clinical team. The Clinician is our quarterly newsletter that focuses on hospice pharmacy, drugs and guidelines updates. Some of the hot topics in our newsletters include Opioid Infusions in Hospice Patients, COPD and Inhaled Corticosteroids, and Diabetes Management Decisions in Hospice. There are over 10 years of past issues of The Clinician archived on our web-site for easy access. Our clinical blog articles are posted more frequently on our website to address timely clinical issues to help you stay current on drug information and other hospice related topics.
We provide three different types of educational presentations: a monthly webinar series called Pathways to Success, customized live in-service presentations tailored to the clients’ needs, and pre-recorded self-paced educational presentations. We are accredited by the California Board of Registered Nurses to offer nursing continued education (CE) credits and all of these presentations are available for nursing CE. Pathways To Success Live Webinar Series is our monthly continuing educational series provided via web-based interactive presentations. The webinars feature guest speakers or HPS/OR clinical pharmacists on various hospice related topics such as Referral Inquiry to Admission: Growing Your Census, Management of Delirium in the Hospice Patient, and many more. In addition, our clinical pharmacists also design and provide clinical education on topics that our hospice partners are interested in and provide live in-service presentations. Some of the very population educational presentations were recorded and made available as self-pace webinar courses, which our hospice partners can register online and complete at your own convenience.
Our exclusive member login website contains an extensive selection of various clinical resources, charts, protocols, clinical algorithm and pathways, and other tools to assist hospice clinicians in many areas of practice. These are printable documents that hospice providers can keep in their pockets for convenient access. A few examples of our clinical algorithms include: Nausea and Vomiting Management, Anxiety and Agitation Management, and Hallucination Management. Another very popular clinical chart is our Inhaled Respiratory Medications Chart, which help clinicians easily identify and avoid therapeutic duplication in respiratory medications.
In addition, we understand that drug discontinuation at end of life may be difficult for patients and families to understand. We have developed handouts on specific drugs recommended for discontinuation in hospice patients. These are written specifically towards patients and family members and nurses have found them helpful as a communication tool. Examples of the handouts include: Discontinuation of Anticoagulants, Cholesterol Lowering Drugs, and Cognitive Enhancement Drugs in end stage dementia.
Hospice Pharmacy Solutions and Outcome Resources provide you with pharmacy clinical support 24/7, 365 days a year with one goal in mind, which is to help you succeed as a hospice provider. Talk to one of our HPS or Outcome Resources representatives to learn more about our clinical services. For more information on our exclusive member login, please visit https://members.outcomeresources.com/memberlogin.asp or contact your Account Manager. We look forward to our future collaboration!
Jim Joyner, PharmD, CGP
The US Food and Drug Administration has issued new labelling requirements for all fluoroquinolone antibiotics due to serious risks for disabling and potentially permanent adverse effects. The new labelling will state that these antibiotics should not be used in patients with uncomplicated infections because the risks generally will outweigh the benefits. FDA mentions these specific infections as examples where Fluoroquinolone risks outweigh the benefits: sinusitis, bronchitis, and uncomplicated urinary tract infections.
The serious risks cited by the FDA include: tendon rupture, peripheral neuropathy, QT prolongation with torsades de pointes, phototoxicity, central nervous system effects, and exacerbation of myasthenia gravis.
Fluoroquinolones have been known to have the potential for serious adverse effects for a long time prior to this latest move by the FDA. In 2008, the FDA required these antibiotics to contain a black-box warning because they increase the risk of tendonitis and tendon rupture by three to four-fold. Other serious reactions reported are: retinal detachment, hallucinations, psychotic reactions, acute kidney failure, depression, painful rashes, and hearing problems.
A 2001 study by Dr. Jay Cohen (1) documented the following fluoroquinolone adverse reaction rates:
a) Nervous system symptoms occurred in 91% of patients (pain, numbness, dizziness, weakness, anxiety, psychosis, and memory loss).
b) Musculoskeletal symptoms in 73% of patients (tendon ruptures, tendonitis, joint swelling)
c) Sensory symptoms in 42% of patients (tinnitus, altered vision, olfactory and auditory disturbance)
d) Cardiovascular symptoms in 36% of patients (tachycardia, shortness of breath, chest pain, palpitations)
Due to the serious risks for major debilitating adverse effects, fluoroquinolone antibiotics should only be deployed in serious infections where other options are not available. It is uncommon that a fluoroquinolone would be the only antibiotic that could be used.
1. Cohen JS. Peripheral Neuropathy with Fluoroquinolone Antibiotics. Annals of Pharmacotherapy 2001, Dec;35(12):1540 47.
Jennifer Chen, PharmD, CGP
Fixed-dose combination therapy offers convenient dosing and improves compliance; however, their place in hospice therapy is limited and these novel inhalers are expensive. This article will discuss new fixed-dose combination therapies, their limitation and the cost-effective alternative for hospice patients.
Inhaled bronchodilators are the cornerstone of treatment in COPD. Both long-acting muscarinic antagonists (LAMAs) and long- acting beta 2-adrenergic agonists (LABAs) are used as long-term maintenance treatment of airflow obstruction in patients with COPD. The fixed-dose combination inhalers are designed to provide extra bronchodilation compared with either therapy alone. Currently, Anoro Ellipta (umeclidinium-vilanterol) and Stiolto Respimat (tiotropium-olodaterol) are the only FDA approved LAMA/LABA combinations available on the market that may be given in a convenient once daily dosing.
Two new LAMA/LABA combination inhalers received FDA approvals but not yet available on the market. Utibron Neohaler (glycopyrrolate-indacaterol) and Bevespi Aerosphere (glycopyrrolate-formoterol), approved in Oct 2015 and April 2016, respectively, offer another option of LAMA/LABA dual combination bronchodilator to patients with COPD. Both inhalers contain the same long-acting muscarinic antagonist, glycopyrrolate, with the different LABAs (indicaterol versus formoterol). Both of these new inhalers are given twice daily.
One of the notable differences between all of these products is the type of inhalation device used. Anoro Ellipta and Utibron Neohaler deliver medication via a dry powder inhaler whereas Stiolto Respimat and Bevespi Aerosphere use a metered-dose inhaler. Both of these devices are breath-actuated, that is, requiring effective positive respiratory effort to inhale medication.
Inhaled corticosteroid (ICS) therapy is recommended as combination treatment with LABA for patients with a history of frequent acute exacerbations of their COPD. Breo Ellipta, approved in April 2015, combines the new LABA vilanterol with an inhaled corticosteroid already on the market, fluticasone. Vilanterol allows this product to be dosed once daily compared with existing ICS/LABA combination products that are dosed twice daily including Advair Diskus (fluticasone-salmeterol), Symbicort (budesonide-formoterol) and Dulera (mometasone-formoterol).
Long-term ICS treatment is associated with multiple adverse effects including fractures, oral fungal overgrowth and respiratory infections. Therefore, treatment with ICS in patients with COPD should be carefully evaluated when assessing the risk/benefit ratio due to the risk of pneumonia. Their benefit in patients at low risk of exacerbations is questionable1.
Place in hospice therapy
The major disadvantage of these combination therapies for the hospice patient is the method in which the medication is delivered via a metered-dose inhaler or a dry powder inhaler. In patients with advanced disease, who may not have enough positive inhalation, nebulized therapies may be more efficacious than inhalers. Therefore, the combination treatment of short-acting muscarinic antagonist (SAMAs) and short-acting beta 2- adrenergic agonist (SABAs), such as DuoNeb (ipratropium-albuterol) is usually recommended as an alternative. Routine use of DuoNeb should provide an equivalent coverage compared to LAMA/LABA combination products. Although the dosing frequency (four times daily) may be considered as a drawback compared to the long-acting combination products, the short-acting combination therapy may also be used on as-needed basis for acute management of dyspnea in addition to the scheduled dosing. Since the newer combination products are generally cost prohibitive, DuoNeb also serves a cost-effective alternative for hospice patients. In cases where a patient has high risk of exacerbation, a low dose oral corticosteroid may be considered and they are inexpensive compared to inhaled corticosteroids.
A complete chart on inhaled respiratory medications with dosing information and pricing can be found in the Clinical Resources in our member section.
Jim Joyner, Pharm.D., C.G.P.
CMS has established very restrictive regulatory criteria for the use of Haloperidol and other psychotropic drugs for patients who reside in the SNFs. These criteria include restrictions on indications for use, duration of therapy, daily dose limits, monitoring, and more. The information is spelled out in F-329 Unnecessary Drugs (CMS Skilled Nursing Facility Regulations). The regulations are intended for nursing home patients who are NOT being treated under “end of life care” and this is clearly spelled out in F-329.
F-329 Unnecessary Drugs contains specific language that provides an exception to the specific criteria for antipsychotic drug use (including Haloperidol) for hospice patients in the SNF. Subsection 483.25 (l) in this F-tag contains an extensive table (Table 1) which lists examples of numerous medications for which CMS is concerned about, including all antipsychotic drugs. At the end of this extensive table is a section titled, simply, “Exception”. Here is the exact language:
This means that when Haloperidol (or any antipsychotic drug) is being used for managing symptoms at end-of-life in the SNF, the regulatory criteria on max dosage, duration of therapy or related issues do not apply. Haloperidol is used extensively in hospice and palliative care for management of terminal delirium, severe agitation of end-stage dementia, and for management of nausea – vomiting. It is highly effective for these indications and generally well tolerated in many hospice patients, however in many cases, doses greater than 2 mg per day are required and are clinically appropriate. Haloperidol is recommended as a drug of choice for terminal delirium by several well respected palliative care experts and organizations (references available upon request if you need them).
Make sure that the patient’s health record clearly indicates that the patient is under hospice for ‘end of life’ care.
|Thank you! We've been getting pushback from NH Facilities recently on what would normally be considered mild dosages for a hospice patient. I've passed out copies of this to all our Nurses.
Posted 5/20/2016 07:13:16 AM
|How does this relate to the more recent CMS initiative to decrease anti-psychotic use in LTCFs by 15%? We have facilities whose star ratings are being affected by the use of Haldol for N/V. Additionally, a patient cannot utilize the hospice benefit and the SNF benefit simultaneously so wouldn't that immediately eliminate our patient population?
-- Jess Smith
Posted 5/2/2016 12:56:58 PM
Jennifer Chen, PharmD, CGP
Last year, the FDA released a drug safety communication, which cautioned the use of SGLT2 inhibitors, due to case reports of ketoacidosis in patients who were being treated with these medications. Recently, the FDA has updated the labels for SGLT2 inhibitors to include the risks for both ketoacidosis and serious urinary tract infections. Patients in these case reports were found to start with urinary tract infection, which then progressed to potentially fatal urosepsis and pyelonephritis that required hospitalization or dialysis to treat kidney failure. Patients who continue to take these medications should be taught to recognize the symptoms of ketoacidosis, which include nausea, vomiting, abdominal pain, fatigue and difficulty breathing. Ketoacidosis can occur even if their blood glucose is not excessively high. Patients with suspected ketoacidosis should stop taking the SGLT2 inhibitor and receive treatment promptly. Clinicians are encouraged to report any side effects to the FDA MedWatch program.
SGLT2 inhibitor is a class of diabetic medication that works by stopping glucose from being reabsorbed into the blood. Medications in this class include Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin).
The FDA imposed the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetic medications in 2010 due the concern of possible increased cardiovascular risk. It required healthcare providers to obtain a special certification in order to prescribe rosiglitazone and patients receiving rosiglitazone must be enrolled in the REMS program. In 2013, the FDA lifted the restrictions for the prescribing and use of rosiglitazone based on the data from RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes) trial. The RECORD trial demonstrated no elevated cardiovascular risk. Recently, the FDA has lifted the entire REMS requirements for rosiglitazone-containing medications, which includes Avandia (rosiglitazone), Avandamet (rosiglitazone-metformin) and Avandaryl (rosiglitazone-glimepiride) on the basis of post-marketing data and the RECORD trial. However, most of these medications have either been removed from the market (Avandamet and Avandaryl) or are rarely used in patients (Avandia).
The FDA gave final approval in December 2015 to Basaglar (a copycat version of insulin glargine). Basaglar was not approved as a “biosimilar” product although it was demonstrated to be similar enough to another insulin glargine on the market (Lantus) regarding its effectiveness and safety. It is administered subcutaneously with the manufacturer’s KwikPen injector once daily at any time of the day. Being as the first “follow-on” insulin glargine product, Basaglar received much attention for potentially lower costs. Basaglar has already launched in the UK under the brand name of Abasaglar and is priced 15% lower than Lantus (listed price of £35.28 for Abasaglar and £41.50 for Lantus according to UK Medicines Information). Pricing for Basaglar in the US is unknown at this time and the drug will not be available until after December this year.
1. FDA. FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections. http://www.fda.gov/Drugs/DrugSafety/ucm475463.htm Accessed on January 10, 2016.
2. FDA. Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS). http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm477601.htm Accessed on December 28, 2015.
3. FDA. FDA approves Basaglar, the first “follow-on” insulin glargine product to treat diabetes. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm477734.htm Accessed on December 28, 2015.
Esther Liu, PharmD, MSIA, CGP
The Center for Medicare and Medicaid Services (CMS) released a new online dashboard that contains some interesting analyses of Medicare Part D drug utilization. The new dashboard presents drug data collected from Medicare Part B and Part D providers from 2010 to 2014. In an analysis of the top 15 drugs by total annual cost for Medicare Part D 2014, 10 out of the top 15 high cost medications are drugs that commonly show up on newly admitted hospice patients’ medication profiles. The remaining 5 medications are all specialty medications used for chemotherapy, immunotherapy or hepatitis C treatment. These 5 medications are curative in nature and are not typically encountered by hospice providers.
The 10 high cost drugs identified by the analysis are Nexium, Crestor, Abilify, Advair, Spiriva, Lantus, Januvia, Duloxetine, Lyrica, and Namenda.
Outcome Resources also targets these medications for our hospice providers in patient medication reviews and monthly drug utilization reviews. Many of these can be switched to a more cost-effective alternative or safely discontinued at the end of life. Below are the common recommendations provided by Outcome Resources clinicians to manage hospice patients who are on the drugs listed above:
If you are interested to learn more about the Medicare Drug Spending Dashboard 2014, the direct link is: <https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Dashboard/Medicare-Drug-Spending/Drug_Spending_Dashboard.html>
Jennifer Chen, PharmD
Proton pump inhibitors (PPIs) and histamine H2 antagonists (H2 blockers) are the most common medications prescribed for the treatment of gastroesophageal reflux disease (GERD) or peptic ulcer disease (PUD). The treatment usually begins with antacids or over-the-counter H2 blockers for mild symptoms. Then steps up to PPIs or higher dose of H2 blockers for moderate to severe symptoms. Occasionally, PPI and H2 blocker may be combined to treat certain patients. This article will discuss the appropriateness of combination therapy and its associated risk.
Hospice patients are predisposed to PUD due to many risk factors including the age-related change in gastric mucosal defense, serious illness and long-term use of NSAID. The majority of patients are managed clinically with a once daily dose of a PPI. The unofficial use of twice daily dosing of PPI or the addition of a nighttime H2 blocker to the daytime PPI therapy may be required for optimal control in a subset of patients such as those with Barrett’s esophagus or extra-esophageal disease (1).
PPIs and H2 blockers have overlapping mechanisms of actions, which ultimately suppress gastric acid secretion, but at different stages of production. When used together, the extensive acid suppression therapy may decrease the absorption of certain nutrients (i.e. vitamin B12, iron and calcium), which are dependent upon an acidic environment to be absorbed in the stomach. There is also a significant risk of hip fractures with long-term PPI treatment. This risk theoretically may be further increased with the combination therapy due to impaired calcium absorption. Combination therapy may also increase the risk of gastrointestinal infections. A recent meta-analysis evaluated Clostridium difficle (C.diff) infections in patients receiving PPIs and found an association between PPI use and an increased risk of C diff (2). H2 blockers have been showed to carry a lower risk for gastrointestinal infection compared to PPIs. However, when both PPIs and H2 blockers are used together, the further reduction of gastric acid may allow for bacteria to multiply in the digestive system and the risk of infection may be increased.
In general, long-term combination therapy does not offer any additional benefit for the management of GERD and may only be appropriate in a particular subset of patients (i.e. Barrett’s esophagus or extra-esophageal disease). Practitioners are encouraged to re-evaluate patient’s condition and consider discontinuation if patient no longer exhibits symptoms or has no indication for continued use. Since PPIs provide superior acid suppression, healing rates and symptom relief compared to H2 blockers, our recommendation is to discontinue H2 blockers over PPIs. If it is determined PPI is no longer indicated for a patient, it should be tapered to avoid rebound acid reflux. For patients who require long-term PPI therapy, the lowest effective dose should be considered.
Jennifer Chen, PharmD
Entacapone is a reversible and selective inhibitor of catechol-O-methyltransferase (COMT). By disrupting levodopa breakdown, the COMT inhibitors can potentiate the effect of levodopa for managing the motor symptoms of Parkinson’s disease. Therefore, entacapone is used as adjunctive treatments in patients who are experiencing “wearing off” or other motor complications during treatment with carbidopa-levodopa.) It is available alone as Comtan® or in a fixed-dose combination with carbidopa-levodopa as Stalevo®.
In August 2010, FDA alerted patients and health care professionals about the increased risk of cardiovascular events and death with the use of Stalevo. The possible safety issue was observed in a clinical trial called Stalevo Reduction in Dyskinesia Evaluation in Parkinson’s disease (STRIDE-PD) and in meta-analysis involving 15 clinical trials comparing Stalevo with carbidopa-levodopa. Since carbidopa-levodopa has been used extensively and has not been associated with cardiovascular risk, the FDA was concerned that entacapone might have been responsible for the increased risk. It was difficult to draw conclusions from these clinical trials because they were not designed to evaluate entacapone’s cardiovascular safety.
Until recently, two studies were examined to understand the significance of cardiovascular risk with entacapone. One was a retrospective cohort study using data from an electronic commercial insurance database and found the risk for myocardial infarction was not significantly increased in patients 18 to 64 years old with Parkinson’s disease treated with entacapone compared to the control group(1). The other study assessed the risk of myocardial infarction, stroke or death in Medicare patients at least 65 years old with Parkinson’s disease and the result did not support an associate between entacapone use and increased cardiovascular risks(2).
Therefore, on October 26, 2015, the FDA announced that entacapone does not carry an increased risk of cardiovascular events based on recent studies. However, patients and health care professionals are still encouraged to report side effects with Comtan or Stalevo to the FDA.
We want to share some exciting news with you regarding Outcome Resources!
On October 30, Hospice Pharmacy Solutions merged Outcome Resources into its operation. The merger is very beneficial for our clients as we will be able to offer you additional unique and innovative solutions geared specifically to the hospice industry.
The business will be headquartered in Dallas, which is a central location, and operate as Hospice Pharmacy Solutions, LLC. In approximately six months, we will retire the Outcome Resources name.
We want to reassure you that while the name is changing, the exceptional service you have come to expect from Outcome Resources remains the same. This merger gives us the ability to enhance our programs and provide hospices valuable resources to better serve their patients.
You can find more details in this press release, including the new leadership structure.
We’d like to once again thank you for your services to patients and their families at a most vulnerable time in their lives. The work you do is honorable, and we are proud to support your mission.
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Education Resources and Support for Hospices
Stay up-to-date on the latest hospice pharmacy benefits management information and tools with a variety of education resources and support at no extra charge. We offer presentations live at your facility, over the Internet or viateleconference, online service education programs, customized courses, and courses accredited for nursing continuing education credit.
Our palliative care experts provide clinical consulting on important medication management and care decisions. Our non-dispensing pharmacists provide focused attention and unbiased advice.
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