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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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Outcome Resources Pharmacists Mentor Future Healthcare Leaders

Dr. Esther Liu, PharmD, CGP, MSIA

Through the recent collaboration with the student chapters associated with Academy of Managed Care Pharmacy, Outcome Resources organized a shadowing opportunity to two inspirational pharmacist candidates, Sora Yoon and Jennifer Vu, from Western University. We shared our experiences about pharmacists’ involvement in a managed care and hospice care setting. The students found this experience to be “incredibly educational and inspiring.”  The pharmacists from our clinical team at Outcome Resources are excited and proud of our preceptorships to future pharmacy leaders. We are committed to participate in many more of these similar events in order to share our knowledge in hospice as well as to provide a unique training opportunity in a managed care setting to our future healthcare leaders.

Inspiring future pharmacists to develop expertise in the specialized focus of hospice and palliative care will benefit future patients, and at Outcome Resources, patient care is our #1 priority.


New Evidence to Support Routine Discontinuation of Statin Therapy in Hospice

Esther Liu, PharmD, MSIA, CGP

It is often difficult for hospice providers to make a recommendation to patients and their family caregivers regarding discontinuation of medications. Most of the patients have been told that they need to take their chronic medications, such as a statin, for the rest of their life to prevent strokes. In fact, the benefits of statin therapy in the past research studies are all estimated on a patient population with a life expectancy of more than 10 years. In theory, the benefit of statin therapy in terminal patients is not significant enough to outweigh the risk of adverse effects, but we did not have much evidence to back up this theory in the past. Finally, there is some solid evidence published by the Journal of Clinical Oncology in June of this year to support our recommendation regarding discontinuation of statin for terminally-ill patients.

This study is a multisite randomized controlled trial of continuing versus discontinuing statins in the setting of life-limiting illness. It included patients with advanced life-limiting illness on a statin for more than 3 months for primary or secondary prevention, a life expectancy of greater than one month, and evidence of recent deterioration in performance status. The study found that the group discontinuing statins lived longer (Time-To-Death: 229 days vs. 190 days), had a better quality of life (McGill QOL scale: 7:11 vs 6.85) and exhibited less symptoms (Edmonton Symptom Assessment Scale: 25.2 vs. 27.4). In addition, there were only a few participants in either group that experienced cardiovascular events and the event rate was similar in both groups of patients. The researchers concluded base on the result of this study that it is unlikely that harm will accrue when statins are discontinued and these patients may even benefit from discontinuation of this medication at a palliative care setting.

This new evidence reinforced our previous recommendations to discontinue statins routinely for patients enrolling into hospice programs with a life expectancy of 6 months or less. It provides solid evidence for us and your hospice staff to share with patients, caregivers, and primary physicians who have difficulty with the decision on statin discontinuation. For more details regarding the study please follow the link in the reference session to view the study abstract published at the 2014 American Society of Clinical Oncology annual meeting. Here is a list of the statins available on the market:

• Lipitor (atorvastatin)
• Zocor (simvastatin)
• Pravachol (pravastatin)
• Lescol (fluvastatin)
• Mevacor (lovastatin)
• Altoprey (lovastatin ER) – Brand only
• Livalo (pitavastatin) – Brand only
• Crestor (rosuvastatin) – Brand only

A Abernethy, J Kutner, P Blatchford, et al. Managing comorbidities in oncology: A multisite randomized controlled trial of continuing versus discontinuing statins in the setting of life-limiting illness. 2014 ASCO Annual Meeting. Accessed July 23rd 2014: http://abstracts.asco.org/144/AbstView_144_135132.html

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Update on Hospice & Medicare Part D: Revised Guidance thanks to Hospice Advocacy

At Outcome Resources, “Helping Hospices Succeed” is more than just a tagline, it is our mission and our primary focus every day. As we consult with our hospice partners, patient care is our number one priority. With patient care impacted by Medicare Part D guidance issued by CMS, Outcome Resources has provided our hospice partners with education via live webinars and consultations and supporting documentation via our Medication Reviews, and then we worked with NHPCO and the Hospice Action Network to change the rules.

As the sole hospice pharmacy partner to sponsor the Hospice Action Network Advocacy Intensive last month in Washington D.C., we are proud that our commitment to hospice advocacy has helped to result in revised guidance being issued by CMS. In addition to our team traveling to D.C. to meet with Congress, we also provided scholarships to 22 attendees of this year’s Advocacy Intensive from around the nation, to ensure that as many legislators as possible were reached with this very important message regarding hospice and Medicare Part D. Thanks to all of us in the hospice community, including those of you who participated by calling in to speak with your congressmen and senators, our voices have been heard!

Revised guidance has been issued as of July 18th. This revised guidance does provide substantial relief of the burden for hospice providers since prior authorizations will only be required on the four categories identified as typically used in hospice: analgesics, antinauseants (antiemetics), laxatives, and antianxiety drugs (anxiolytics). Other drugs will not have to go through the PA process. You may read the full CMS Memo for more information.
We urge you to make special note that the guidance emphasizes the need for hospices to include a comprehensive written drug profile as part of the hospice plan of care. While this Medication Review meets the need for Conditions of Participation, it now also may be provided to a Part D sponsor during the PA process. Outcome Resources has provided the most comprehensive, best in industry Medication Reviews well before these requirements were put in place. We invite you to compare our Medication Reviews to what you are currently receiving. While these are the #4 reason for being cited in survey, no Outcome Resources partner has ever been cited for Medication Reviews.

To learn more about hospice advocacy and the hospice regulatory environment, join us at the Annual Pathways to Success Hospice Conference this November in Berkeley, California. Jon Keyserling of NHPCO will address Hospice Advocacy and Policy in 2015, and Susan Balfour will discuss Hospice and the Letter People, and how to keep up with regulatory changes. Drs. Glen Komatsu and Stephen Leedy will keynote the two day Conference, and you may earn up to ten contact hours of continuing education. View the Full Agenda and Register Today!

Photo: Outcome Resources CEO Dr. Martin McDonough Addresses Attendees at the Hospice Action Network Advocacy Intensive, June 2014

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