Jennifer Chen, PharmD, CGP
PharmaTech is recalling all liquid products due to a potential risk of product contamination with B. cepacia. This recall is to the retail/consumer level. The affected product started shipping October 20, 2015 and the affected companies include Rugby, Major, Bayshore, Metron, Centurion and Virtus. Besides Diocto liquid as previously posted, Senna syrup, Senexon liquid and various liquid vitamins are also affected in this recall. More information regarding recalled drug products, NDC number and lot number can be found on the FDA website. It is advised to check your patients who are currently using these products and evaluate if they are affected by this recall. Our client may request a claim report to be generated to help identify which patients are impacted by this recall at your hospice.
Jennifer Chen, PharmD, CGP
PharmaTech, the manufacturer of the Rugby-branded product is recalling all non-expired lots of the stool softener, Diocto (docusate sodium) Liquid due to a risk of product contamination with B. cepacia. As mentioned in previous blog article, the use of oral docusate liquid contaminated with B. cepacia may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions.
Diocto Liquid comes in one pint (473mL) bottles and was distributed nationwide to wholesale and retail facilities including hospitals and pharmcies. All lots with the NDC 0536-0590-85 (50mg/5ml) are included in the recall. The FDA and CDC continues to recommend that clinicians and patients not use liquid docusate sodium product from any manufacturer for any medical purpose.
Jennifer Chen, PharmD, CGP
Last month, the CDC and FDA investigated a multi-state outbreak of infections caused by Burkholderia cepacia complex. B. cepacia complex is normally not a pathogen in the ambulatory setting, but may colonize and/or infect the respiratory tract of patients with cystic fibrosis or bronchiectasis. Symptoms can vary widely, ranging from mild respiratory symptoms to serious respiratory infections, especially in patients with compromised immune system. The reported infections were primarily in ventilated patients without cystic fibrosis and who were being treated in intensive care units. Preliminary information indicated that contaminated liquid docusate products may be related to these cases. At the time, the CDC recommended that facilities not use any oral liquid docusate products for patients who are critically ill, ventilated or immunosuppressed.
The CDC is continuing to work with the FDA to investigate this issue. Forty-seven B. cepacia complex cases have now been confirmed in five states. The CDC also confirmed that two samples of unused oral liquid docusate product received from one of the affected hospitals have tested positive for B. cepacia complex. The FDA is currently testing multiple liquid docusate products that are linked to the cases.
The CDC has now expanded the warning to all patient populations, including hospice patients, and recommends that clinicians not use any liquid docusate product, as a stool softener or for any other medical purpose. Patients who are currently using oral liquid docusate as laxative should be transitioned to an alternative product such as senna-docusate tablet (may be crushed), liquid senna, sorbital or Milk of Magnesia.
B. cepacia bacteria are often resistant to common antibiotics and decisions on the treatment of infections should be made on a case-by-case basis. Healthcare providers should remain on alert for infections caused by B. cepacia complex and inform infection prevention staff immediately when these infections are identified. Cases should be reported to state or local public health authorities. More information and further updates regarding this outbreak can be found on the CDC website.
Jennifer Chen, PharmD, CGP
Nuplazid (pimavanserin) has recently received FDA approval for the treatment of hallucination and delusion associated with Parkinson’s disease. It is an antipsychotic medication targeting only on the serotonin pathway. The FDA approval was based on a 6-week, randomized, placebo-controlled study (1). In this study, 199 patients were randomized in a 1:1 ratio to Nuplazid 34mg or placebo once daily. The treatment group resulted in a 37% improvement compared to a 14% improvement for those taking placebo. There are currently no head to head studies comparing Nuplazid with existing antipsychotic medications.
Typical Parkinson’s disease therapy consists of drugs that stimulate dopamine to treat the patient’s motor symptoms such as tremor and muscle rigidity. Existing antipsychotics target both the dopamine and serotonin pathways in the brain and so they can interact with the pathways that help regulate the movement disorders in Parkinson’s patients. Nuplazid, as a selective serotonin inverse agonists (SSIA), preferentially binds to 5-HT2A receptors and has no activity at dopamine receptors so it is not likely to aggravate Parkinson’s disease.
Nuplazid is supplied as tablets for oral administration and is now available in the United States. The recommended dose is 34 mg per day, taken orally as two 17-mg tablets once daily, without titration. There is no dosage adjustment needed for patients with mild to moderate renal impairment. However, the use is not recommended for patients with severe renal and hepatic impairments as it has not been evaluated in these patient populations. The dose should be reduced to 17 mg per day when taken with a potent CYP3A4 inhibitor such as statins or ketoconazolethe.
The most common adverse effects noted in the clinical trial were peripheral edema and confusion. Similar to existing antipsychotic medications, Nuplazid comes with the black box warning regarding the increased mortality in elderly patients with dementia-related psychosis. It also prolongs the QT interval so the risk of the occurrence of torsade de pointes is increased in patients with known QT prolongation or in combination with other drugs known to prolong QT interval. Therefore, Nuplazid should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval and should also be avoided in patients with a history of cardiac arrhythmias and the presence of congenital prolongation of the QT interval.
Place in Hospice Therapy
Although Nuplazid has a novel molecular approach to treat Parkinson’s psychosis, its use may be limited in the hospice setting. It has a very long half-life of 57 hours and takes 12 days to reach steady state. According to the phase 3 trial, the significant difference in the efficacy between Nuplazid and placebo was not seen until week 4. In addition, Nuplazid can be cost-prohibitive ($2340 per month) compared to existing antipsychotics, which are available as generics. Atypical antipsychotic such as Seroquel, has less anti-dopaminergic properties and demonstrated efficacy on Parkinson’s psychosis in clinical studies, so it is more cost effective than Nuplazid in the management of Parkinson’s psychosis.
Nuplazid® [package insert]. San Diego, CA: Arcadia Pharmaceuticals, Inc; 2016.
|That is disturbing that FDA would approve this drug after such a small, short trial, with limited benefit relative to placebo.
Posted 7/13/2016 08:29:23 AM
Jenny Chau, RDH, PharmD
Brintellix (vortioxetine) is a relatively new serotonergic antidepressant, approved to treat major depressive disorder in September 2013, as described in our previous blog. In recent FDA MedWatch news, there were numerous reports of name confusion between Brintellix and the antiplatelet drug, Brillinta, not only among the consumers, but also among healthcare professionals. On May 2, 2016, the FDA approved a brand name change from Brintellix to Trintellix in order to decrease the risk of prescribing and dispensing errors. As of June 2016, Brintellix will be marketed as Trintellix and will also have a new National Drug Code (NDC).
Although there is a new brand name and NDC, the formulation, indication and dosages of 5 mg, 10 mg and 20 mg tablets will remain the same. Pharmacies, insurance carriers and healthcare providers are advised to update their medication-related electronic systems with the new brand name. During the transition to the new brand name, healthcare providers are also advised to carefully check to make sure they have prescribed or dispensed the correct medication and educate patients about the name change.
The FDA also encourages patients and healthcare professionals to report medication errors, name confusion, adverse events or side effects related to the use of vortioxetine (Brintellix/Trintellix) and Brillinta by calling FDA’s MedWatch Program at 800-332-1088 or visit http://www.fda.gov/Saftety/MedWatch.
FDA Drug Safety Communication: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brillinta (ticagrelor). (2016, May 2). Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm497942.htm.
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
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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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