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New Research: ABH Topical Gel vs Placebo Controlled Clinical Trial for Nausea Treatment

Dr. Jim Joyner, PharmD, CGP

The results of a clinical trial of ABH topical gel vs placebo for the management of nausea in cancer patients were recently published in the Journal of Pain and Symptom Management.(1)  ABH topical gel is a pharmacy-compounded product consisting of Lorazepam (Ativan), Diphenhydramine (Benadryl), and Haloperidol (Haldol) usually prepared in a pluronic lecithin organogel (PLO) base. It has been used frequently in some palliative care settings for management of nausea and vomiting, despite very limited scientific data to support continued use. The product has gained a following due to the ease of use (topical administration) and perceived efficacy.

This recent study was a well designed, randomized, double-blind, placebo controlled, crossover clinical trial to compare the effectiveness of ABH topical gel against a placebo gel. The trial was completed with 20 patients who had an active cancer diagnosis. Nausea in these patients was related to the following: pain, pain medication, bone marrow transplant, or related to their cancer. Results of this trial showed no difference in efficacy between ABH topical gel or the placebo gel for treating nausea or vomiting. The researchers concluded that ABH topical gel should not be used in cancer patients experiencing nausea.

The results of this trial are consistent with earlier research on healthy volunteers who received topical ABH gel and had serial blood samples drawn at various intervals up to 4 hours after application.(2) Blood levels of each of the 3 drugs were evaluated. That small study on 10 volunteers, published in 2012, demonstrated that none of the three medications in the ABH gel formulation were absorbed to any significant degree. The researchers concluded that topical application of this product was ineffective.

The data is conclusive that ABH topical gel is not an efficacious product and cannot be recommended.

(Also see our previous 2011 blog article on ABH Gel.)

1. Fletcher, Coyne, Dodson, et al. A Randomized Trial of the Effectiveness of Topical ABH Gel vs Placebo in Cancer Patients with Nausea. Journal of Pain and Symptom Management. Vol 48;5.
November 2014
2. Smith, Ritter, Poklis, et al. ABH Gel is not Absorbed From the Skin of Normal Volunteers.
Journal of Pain and Symptom Management. Vol 43;5 May 2012


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New Spiriva Formulation Available in January 2015

Jennifer Chen, PharmD

A new formulation of Spiriva will be available on the market in January 2015. Both Spiriva Handihaler and Spiriva Respimat contain the same active ingredients – tiotropium.  Tiotropium is an anticholinergic bronchodilator indicated for the long-term, once-daily, maintenance treatment for COPD. This new formulation turning the inhalation powder of tiotropium into inhalation spray is called Spiriva Respimat. The dry-powder inhalation, Spiriva HandiHaler, will continue to be available on the market. Spiriva Respimat provides a pre-measured amount of medicine in a slow-moving mist that helps patients inhale the medicine and is intended to deliver medication in a way that does not depend upon how fast the dry powder is breathed in from the inhaler. This new formulation may reduce the errors involving the inadvertent oral administration of Spiriva HandiHaler capsules for inhalation. 

The results from clinical trial (TIOSPIR) shows Spiriva Respimat had a safety profile and exacerbation efficacy similar to Spiriva HandiHaler device(1). The most common side effects reported include sore throat, cough, dry mouth and sinus infection. One study assessed the effect of switching from HandiHaler to Respimat in patients with COPD shows similar effects and usability but patients experienced cough for the first 4 weeks of switching before they got used to the new formulation. The other finding was that dry mouth appeared to improve after switching to Respimat. However, this study was done on a small group of COPD patients (about 30 patients) and these patients were followed for 12 weeks after switching(2).

With similar costs and efficacy, the use of Spiriva Respimat may be limited in the hospice setting due to its requirement of active inhalation for effectiveness of drug delivery and training of inhaler technique as most end-stage COPD patients do not have effective positive force to inhale medication contents from the inhalers.

Comparison of Spiriva HandiHaler and Spiriva Respimat and Instructions

1. Wise RA, Anzueto A, Cotton D, et al. Tiotropium Respimat Inhaler and the Risk of Death in COPD. N Engl J Med 2013;369:1491-501.
2. Asakura Y, Nishimura N, Maezawa K, et al. Effect of switching tiotropium HandiHaler to Respimat Soft Mist Inhaler in patients with COPD: the difference of adverse events and usability between inhaler devices. J Aerosol Med Pulm Drug Deliv 2013 Feb;26(1):41-5.

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Hospice Medication Alert: Another Long-Acting Hydrocodone Medication is Approved

Jim Joyner, PharmD, CGP

Hysingla ER,  extended-release hydrocodone, has recently been approved by the FDA on November 20, 2014.   This is the second single-entity, extended release hydrocodone medication to be approved in a little over 1 year.  Last fall, Zohydro ER was approved and detailed on the Outcome Resources blog in March of 2014.   Both of these products are intended for routine management of chronic severe pain.  

Hydrocodone analgesics were previously only available in combination with acetaminophen (as Lortab, Norco, or Vicodin) or in combination with ibuprofen (Vicoprofen).    These new products represent a significant increase in hydrocodone unit strengths.   The older combination products contained hydrocodone in strengths of 5 or 10mg, while the two new extended release products are available in single tablet or capsule strengths as high as 50mg (Zohydro ER capsule) or 120mg (Hysingla ER tablet).   The availability of hydrocodone in these new strengths, which are 5 to 10 times greater than the old combination products, have many clinicians very concerned about the potential for serious dosing errors, mis-use, or abuse of these new high-potency opioid products.   Both of these products are being touted by the manufacturers as being free from the risk of acetaminophen induced liver toxicity that may occur with high doses of the older combination products.   While this is true, the greater risk may actually be associated with the much higher strengths of hydrocodone available in these new products.

Hysingla ER has been formulated to reduce the potential for abuse when the drug is chewed and then taken orally, or crushed and snorted, or injected.  The tablet is difficult to crush, break or dissolve. It also forms a viscous hydrogel (thick gel) and cannot be easily prepared for injection. The FDA has determined that the physical and chemical properties of Hysingla ER are expected to make abuse by these routes difficult.  However, abuse of Hysingla ER by these routes is still possible.    Zohydro ER is not currently available in an abuse deterrent dosage-form, however, the manufacturer has applied to the FDA for approval of a new version of the product that would have similar deterrents built into it.  FDA approved Zohydro ER last year amid significant criticism related to the product’s lack of abuse deterrent attributes.   If approved, the new abuse deterrent version of Zohydro ER would be available in the spring of 2015.  

Hysingla ER is designed to release drug over a 24 hour period.  It should be taken just once a day (every 24 hours) on a routine schedule.  It is not appropriate for “prn” usage for breakthrough pain.   Several strengths will be available:   20, 30, 40, 60, 80, 100 and 120mg.   Tablets must be swallowed whole.

Zyhydro ER is designed to release drug over a 12 hour period.   It should be taken every 12 hours on a routine schedule.   Like Hysingla ER, it is not appropriate for “prn” use either.  Zohydro ER is available in the following strengths:  10, 15, 20, 30, 40, and 50mg.   Capsules must be swallowed whole.   Alcohol must be avoided in patients taking Zohydro.  Consumption of alcoholic beverages or the use prescription or non-prescription products that contain alcohol while taking Zohydro ER may result in increased plasma levels and a potentially fatal overdose of hydrocodone.  

The role of these new long-acting hydrocodone products in hospice patients will be very limited due to factors such as high cost and the availability of other long-acting opioids with established track records of efficacy in severe chronic pain (Methadone tablets and solution, Morphine Extended Release dosage-forms, etc.)  


Urgent Hospice Medication Alert: Gabapentin Capsule Recall Issued

Jim Joyner, PharmD, CGP

Yesterday, (11/24/2014), Aurobindo Pharma issued a voluntary recall of their Gabapentin 300mg capsules due to some of the capsules being empty. Other strengths are not affected. Only product from this manufacturer is affected. This recall is extended to the patient level. Empty capsules could result in missed dose(s) of gabapentin resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus that could be life-threatening. Aurobindo Pharma has not received any reports of adverse events related to this recall as of yesterday, but has received four complaints for empty capsules. 

The affected Gabapentin lot is GESB14011-A, Expiration 12/2015 and is packaged in 100-count bottles, NDC 16714-662-01. The product can be identified by the imprint D on yellow cap and 03 on yellow body with black edible ink. Product was distributed through Northstar label to retail outlets nationwide.

Outcome Resources is including this information on our blog for the hospice clinicians since Gabapentin is widely used in hospice for a variety of indications and this news may impact your patients. It is advisable to check with your patients who have current orders for Gabapentin and evaluate if they are affected by this recall.  If you suspect that one of your patients has the affected product, call the pharmacy which dispensed the prescription and have the prescription label in hand to provide necessary information to the pharmacist.  In the event you encounter the recalled product, return it to the pharmacy that dispensed it for a replacement. 

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Hospice Medication Alert: Movantik for Opioid-Induced Constipation

Sora Yoon, Pharm.D. Candidate 2015, Western University of Health Sciences

FDA has recently approved a new medication for opioid-induced constipation: Movantik (naloxegol), an opioid antagonist manufactured by AstraZeneca. Used in adults with long-lasting chronic pain that is not caused by cancer. Movantik is dosed once daily on empty stomach 1 hour before first meal of day in the morning or 2 hours after meal. It should not be taken concomitantly with other laxatives.

According to AstraZeneca website, Movantik 25mg was studied in 446 patients lasting 12 weeks. Results showed 44% of patients had ≥3 spontaneous bowel movements (SBMs) per week and a change from baseline of ≥1 SBM per week for at least 9 out of 12 weeks as well as 3 out the last 4 weeks. 61-70% of patients had a SBM within the first 24 hours of first dose. Safety and efficacy were studied in 1146 patients for six to twelve months supporting the safety and tolerability profile of Movantik.

Movantik does carry two specific warnings: gastrointestinal perforation and opioid withdrawal. Gastrointestinal perforation has been reported with use of another peripherally acting opioid antagonist in patients who may have localized or diffused reduction of structural integrity in the wall of their gastrointestinal tract. Hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning are consistent with opioid withdrawal symptoms. Combination of three or more of these symptoms are defined as possible opioid withdrawal, but must occur within the same day and not related to gastrointestinal system. Patients who receive methadone for pain control have experienced higher frequency of gastrointestinal adverse reactions related to opioid withdrawal than any other opioids. Also, patients who may have disruptions in the blood-brain barrier (BBB) may be at increased risk for opioid withdrawal or reduced analgesia. The most common adverse reactions reported in ≥3% of patients are abdominal pain, diarrhea, nausea, flatulence, vomiting, and headache. Movantik will be distributed with a medication guide that instructs on its use and information on potential risks.

Currently, on the market is Relistor (methylnaltrexone) with same indication for use and limited ability to cross the BBB. It mainly blocks the µ-opioid receptors in the gastrointestinal tract that causes opioid-induced bowel dysfunction and does not interfere with analgesic effects. It is administered subcutaneously, making it an invasive medication, which may not be appropriate for patients at end-of-life.

Movantik is a schedule II controlled substance due to its structural similarity to noroxymorphone; however, AstraZeneca has filed a petition to US DEA for descheduling, as it has no risk of abuse or dependency. Proposed planned launch of Movantik will be the first half of 2015.

Opioids are the most commonly prescribed class of drugs in the U.S., accounting for over 240 million prescriptions a year. They are increasingly being used to treat chronic pain, both cancer and non-malignant conditions. At end-of-life, long-term pain management with opioids is highly required for palliative care, with that comes opioid-induced constipation. Therefore, it is important to start patients on laxatives when starting opioids. In hospice care, Movantik would be last line of use, due to its cost and specific warnings. With many patients having a decline in debility, this drug may not be warranted for use as it can cross the BBB, which can then affect patients’ ability to take medications by mouth and lead to further complications. Once a patient has exhausted other options, can this medication be considered given the patient’s current state at that time.

1. Movantik [package insert]. Wilmington, DE: AstraZeneca; 2014. http://www.azpicentral.com/movantik/movantik.pdf#page=1
2. Tack, J. and Corsetti, M. “Naloxegol for the treatment of opioid-induced constipation.” Expert Review of Gastroenterology & Hepatology. 2014:1-7.


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Pathways to Success Conference By the Bay 2014

Penelope Gatlin

Outcome Resources' second Annual Pathways to Success Conference by the Bay was held last week, November 12th-13th, at the Claremont Hotel Club and Spa in Berkeley, California. Hospice and palliative care professionals from around the nation gathered to hear real-world success stories from top leaders and implement their strategies for success. Topics included medication management of dementia, providing pediatric concurrent care, cost reduction strategies, strategic management and compliance, discussions about grief and hospice advocacy and policy in the year ahead. In addition to her session “Helping People Find Hope after Loss,” top grief expert Dr. Gloria Horsley filmed interviews of participants for the Open to Hope YouTube Channel, NHPCO’s VP of Public Policy Jon Keyserling shared major policy changes faced by hospices and the overall policy environment, and a panel of industry leaders reviewed difficult hospice patient case studies in a session with interactive audience participation. This year’s Dr. MJ McDonough Award for Distinguished Service in Hospice was presented to Kitty Whitaker, CEO of Hospice by the Bay. In addition to valuable education, participants were also treated to a fun San Francisco Bay Dinner Cruise, complete with beautiful views of the city skyline, Alcatraz, and the Bay and Golden Gate Bridges. Outcome Resources would like to thank all the hospice nurses, clinicians, medical directors, administrators, CEO’s, and speakers that helped to make this year’s Pathways to Success a success. And a special thank you also to our sponsors who help make our conference possible: Complete Delivery Solution, Sharp HospiceCare, Accreditation Commission for Health Care, CVS Health, Mumms Software, Elsevier, Neptune Society of Northern California, Horizon Oxygen and Medical Equipment, and Coalition for Compassionate Care. We hope you will join us at a future Outcome Resources event!


New DEA Regulations on Disposal of Controlled Drugs

Jim Joyner, PharmD, CGP

The Drug Enforcement Agency (DEA) recently released new regulations governing the disposal of controlled drugs by the ultimate user (patient to whom the medication was prescribed).  The new regulation does not prohibit the patient or family member (member of the same household)  from disposing of medications in their home.  It expands the options for this disposal to include and encourage the use of authorized collectors which will include pharmacies, hospitals, clinics with pharmacies, certain manufacturers, distributors, and law enforcement agencies. All of the aforementioned collection options are voluntary and the regulation does not require the patient to utilize any of these methods for disposal of controlled substances. This regulation does not prohibit the patient (or family member within the household) from using current existing lawful methods for drug disposal. Any method of drug disposal that was valid prior to the new regulation continues to be valid. In the event that the patient has died, any person lawfully entitled to dispose of the decedent’s property may dispose of the controlled substances. The hospice should encourage their clients  to use  authorized collectors for this disposal to help protect the environment and reduce the risk of drug diversion, but it is not mandatory. 

We have included some downloadable files with more details:

•         DEA Final Rule on Destruction of Controlled Drugs
•         Disposal Act Public Fact Sheet (FAQs)
•         Disposal Regs Registrant Fact Sheet (FAQs)


Medihoney for Pressure Ulcers in Hospice Patients

Esther Liu, PharmD, MSIA, CGP
Kristen Brodrick, RN, BSN, CHPN, CWCN

Recently, I have had several nurses inquiring about the application of Medihoney dressing for hospice patients with pressure ulcers. It has become more popular because there was a study suggesting medical honey can inhibit bacterial growth for pressure ulcers and it seems to be a more affordable option in comparison to the other protective products like DuoDerm gel. I want to share some of the findings I have on Medihoney with you.

Regarding to the antibacterial property of honey, it has yet to be confirmed. The referenced study done in 2012 was relatively small (20 patients).1  It was conducted on a group of patients that had participants as young as 30 years old,  so the skin integrity and healing power in this population may be stronger than our typical hospice patients at end of life. The study showed that it took approximately a week to get a clean swab study from the wound bed but there was no controlled group on placebo so we were unsure if that was the time it took the normal skin to eradicate the bacteria or it was eradicated by the honey. If the hospice patient has an infected or odorous pressure ulcer, topical antibiotics, such as topical metronidazole, are preferred over Medihoney to manage the infection due to the confirmed efficacy.

I have discussed this product with a wound care specialist in our northern California region, Kristen Lyn Brodrick, RN, BSN, CHPN,CWCN.   We are in agreement that Medihoney would still be an affordable protective gel option for those patients with dry wound beds.  However, Kristen pointed out that this product is made with honey so it can be very sticky and hard to handle sometimes.   Foam and clear dressings are more convenient, but may add some extra cost. Kristen also recommended Sensi-care (methylcellulose) protective cream for the shallower pressure wounds.  Barrier cream can keep wound bed moist and protected in an area often difficult to have dressing adhere. It comes in a much larger tube with a slightly higher price than Medihoney. Please see below for the AWP pricing on the products mentioned. You may be able to get a better pricing through your local medical equipment supplier.

Medihoney 15gram gel .....  $4.50 per tube
DuoDerm 15gram gel .....  $8.10 per tube
Sensi-Care 85gram Cream .....  $6.00 per tube

In summary, Medihoney is a more affordable option for those with a less complicated pressure ulcer that is dry, but not for those with more shallow or heavily draining wound beds.  It may not be clinically appropriate to use it for the purpose of disinfecting a wound due to the unconfirmed efficacy. Please be cautious when selecting the wound care product for your hospice patients.

1. Biglari B, Linden P, Simon A, et al. Use of Medihoney as a non-surgical therapy for chronic pressure ulcers in patients with spinal cord injury. International Spinal Cord Society. 2012, 50, 165-169.

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Hydrocodone Combination Products Will Become Schedule II Controlled Substances

Dr. Jim Joyner, PharmD, CGP

The Drug Enforcement Agency (DEA) has issued a directive that reschedules ALL hydrocodone combination products from schedule III to the more restrictive schedule II category of the Controlled Substances Act.  DEA has indicated that it took this action based upon evidence and expert advice demonstrating that these products are associated with a significant degree of abuse, misuse, and diversion that presents a hazard to those using the products and the public in general.  Products affected will include numerous brand-name and generic analgesics and cough suppressants. Some common brand-names are provided here:

Norco, Lortab, Vicodin, Vicoprofen

Cough suppressants :
Hycodan, Tussionex

As a result of this action these products will no longer be re-fillable.  A new prescription will be required for each fill.  This may result in the need for increased provider visits.  Some states, such as California and Texas, require triplicate prescription forms for all schedule II drugs which will represent a significant departure from the way these drugs were prescribed in the past.  

This new action will become effective on October 6, 2014,  forty-five days after the directive was published in the Federal Register. 


Nationwide Advance Care Planning Consulting Service Now Available

We would like to let our hospice partners and friends know about an exciting new opportunity. The Coalition for Compassionate Care of California now offers a nationwide Advance Care Planning Consulting Service for healthcare providers.

With healthcare reform, we’re all more aware of the need to provide more effective care for less money. One of the best tools out there for achieving the goals of healthcare reform is advance care planning. 

The Coalition has been working in advance care planning for more than 15 years and is a wealth of information and experience on advance care planning. The Coalition has just started a consulting service as way to bring to you this knowledge and best practices. They can provide you with customized hands-on training, carefully crafted materials, and the support you need to make an impact with your patient population. Whether your organization is large or small, urban or rural, for-profit or non-profit, The Coalition will tailor the program to meet the cultural needs of your organization and the population you serve.

Our CEO, Dr. Martin McDonough, serves on the Coalition Board of Directors and can vouch for the quality of their work. To find out more, Vist the Coalition ACP Integration Systems Site today.

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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 viaEducational Resources and Support for Hospicesteleconference, online service education programs, customized courses, and courses accredited for nursing continuing education credit.

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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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Why Use A PBM?

Contracting with multiple pharmacies, doing all the reporting, trying to stay current with medical practices and stay compliant while keeping costs down? There’s an easier and more effective way.

Find out how using a pharmacy benefits manager (PBM) can help you>>

Why Use a PBM