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 :
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.
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.
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.
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
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
Esther Liu, PharmD, MSIA, CGP
HIS is a patient-level data collection tool developed as part of the Hospice Quality Reporting Program (HQRP), which can be used to collect data to calculate 6 National Quality Forum-endorsed (NQF) Measures and 1 modified NQF Measure. See below for a list of measures required:
1. NQF #1617 Patients Treated with an Opioid who are Given a Bowel Regimen
2. NQF #1634 Pain Screening
3. NQF #1637 Pain Assessment
4. NQF #1638 Dyspnea Treatment
5. NQF #1639 Dyspnea Screening
6. NQF #1641 Treatment Preferences
7. Modified NQF #1647 Beliefs/Values Addressed (if desired by the patient)
HIS is implemented as part of the FY 2014 Hospice Wage Index Final Rule issued last year in July 2013. To refresh your mind regarding HIS submission, you may visit the CMS website to view the training materials. CMS requires ALL Medicare-certified hospices to submit HIS data on ALL patients. Please be aware of the completion and submission deadlines. Data collection of HIS for each admission must be completed within 14 days and submitted to CMS within 30 days after admission. Data collection for HIS for discharged patients must be completed within 7 days and submitted to CMS within 30 days after discharge. If the hospice failed to be compliant in reporting patient admission/discharge data, this would impact its payment rate in fiscal year of 2016.
As a Pharmacy Benefit Manager, we help our hospice partners to collect data to fulfil HIS requirements related to medications. To learn about the different reporting tools we offer to our partners, please contact the clinical department at clinical AT outcomeresources DOT com or Submit Your Information and we will contact you directly.
Jennifer Chen, PharmD
On March 28th, FDA approved the over-the-counter Nexium 24HR (esomeprazole magnesium) 20mg delayed-release capsules. Nexium is part of a class of drugs called proton pump inhibitors (PPIs), which is commonly used for gastroesophageal reflux disease (GERD), erosive esophagitis and prevention of NSAID-induced gastric ulcers. This purple pill, previously available by prescription only, is now available over-the-counter providing patients who suffer from frequent heartburn an easier access.
However, Nexium 40mg delayed-release capsules still remains available by prescription only as well as other formulations of Nexium including Nexium I.V. and Nexium oral suspension. For patients with difficulty swallowing, the Nexium 24HR capsule can be opened and mixed in applesauce.
The status change to OTC does not take away its potential harms. Its side effects include headache, diarrhea, increased infection and bone fractures. In general, short-term use of PPI is safe. The approved OTC labeling is a 14-day treatment and may be repeated every 4 months.
As mentioned in a previous article, Nexium was the number 2 drug in “Top 100 Drugs by Sales” over the past year. The cost for Nexium 24HR is significantly lower than the prescription version (about 1/10th the cost of prescription Nexium). The OTC availability of Nexium 24HR provides another cost-effective alternative for hospice patients. Other PPIs available in OTC formulations are Prevacid (lansoprazole) and Prilosec (omeprazole).
Jim Joyner, PharmD, CGP
One of the most common sources of medication errors is the problem of “look-alike” and/or “sound alike” drug names. The risk for serious errors can arise when medication orders or prescriptions are not written clearly and the reader misinterprets the intended drug for a different drug with a very similar spelling. Another variation on this error theme is when a drug name is transmitted verbally (either directly or more likely, over the phone) which sounds very similar to a different drug. The listener may hear a different drug name than that which was intended. There are very many drugs that fit into these categories of look-alike and sound alike drugs, providing the clinician with a great many opportunities for misinterpretation. This table provides just a few examples. (You may wish to share this with your staff.)
There are a number of ways to reduce the risk for this type of error through increased clinician awareness of the problem, coupled with a variety of safe practices. Here are a few safe practices that are worth consideration:
• Put the drug name that you heard or read into the context of the overall medication order; does the strength, frequency for use, and reason for use make sense for the drug name?
• Know what the medication is intended to be used for. Is the drug name that you heard indicated or commonly used for managing that type of condition or symptom?
• If the person transmitting the order verbally is not clear or has an accent that you are not familiar with, ask them to spell it out.
• When initiating an order in writing or verbally, consider using both the brand name AND generic name.
• When initiating an order, consider including the “reason for use” in the medication order. Such as “for depression” or “for arthritis”.
• When selecting drug line items from a computer data-base, keep in mind that look-alike drug names may appear consecutively in the list, making the incorrect selection a high probability. Double – check all selections for accuracy against the intended drug name.
• Some computerized drug data bases can be configured to change the appearance of look-alike drug names to draw attention to their dissimilarities. This is done with the use of “tall man” (mixed case) lettering.
• Develop a working knowledge of actual look-alike and sound-alike drug names. The Institute for Safe Medication Practices (ISMP) has a very extensive list of drug name pairs that have been reported as error related events of this type. The ISMP list is updated every few months. Refer to http://ismp.org for more information on this topic and other medication error issues.
Outcome Resources considered it an honor to recently sponsor the 2014 Hospice Action Network Advocacy Intensive in Washington, D.C. Together with over 200 hospice professionals we had the opportunity to share our hospice stories with nearly all of the nation’s Senators and State Representatives. In addition, this year, twenty advocates whose hospice programs would otherwise be unable to afford it were able to attend the Hospice Action Network’s Advocacy Intensive thanks to Outcome Resources scholarships. It is vital to bring these stories to Congress and have our voices heard on Capitol Hill.
The support of our elected officials is crucial to protect and preserve the hospice Medicare Benefit and to support legislation that positively affects those patients and families facing end of life. We are grateful to the Hospice Action Network for providing all of us involved in hospice the forum and opportunity to speak with a unified message in support of our daily efforts. During the meetings on the Hill with Representatives, Senators, and Legislative Assistants, this year advocates focused on requesting support with the issue of Hospice and Medicare Part D. (Learn more in our previous blog post about the issue.) As you may be aware, CMS issued guidance to the Part D provider and hospice communities introducing a “prior authorization” process for how the two groups should determine who pays for which drugs once a patient elects hospice. Since there is no uniform process in place, hospices are dealing with multiple Part D prior authorization processes and paperwork that in many cases requires the addition of staff, and patients are trapped in the middle of this confusing process – sometimes even deciding to disenroll from hospice or being left without medications.
To learn more about these issues or how you can help, please visit Hospice Action Network. You can also participate by calling your members of Congress. Outcome Resources has been involved as hospice advocates for many years and will continue to support these efforts at every opportunity. We are honored to have Jonathan Keyserling, Senior Vice President, Office of Health Policy and Counsel at the National Hospice and Palliative Care Organization presenting a session on Hospice Advocacy at the Outcome Resources Pathways to Success Conference by the Bay this November. To learn more about the Conference, visit the Conference Website or Download the Information Sheet.
View our photos of the HAN Advocacy Intensive on Facebook at http://on.fb.me/1m4GXvz.
Dr. Jim Joyner, PharmD, CGP
A recent article appeared in the Medscape News on-line site which presented the “Top 100 Drugs by Sales” over the past year. All of these drugs were brand-name products. The drugs made the list through a combination of two factors; popularity among prescribers and having a high cost. Thirteen of the drugs on this list are drugs that we see routinely prescribed for hospice patients to varying degrees. In light of limited hospice reimbursement rates and extremely tight budgets, it is appropriate for hospice organizations to evaluate current usage of these highly prescribed, high cost drugs. The remainder of this article will identify these drugs and discuss possible cost-effective alternatives.
First, the 13 drugs are presented here with corresponding reported $ sales figures for the past year (April 2013 – March 2014). Drugs are ranked from highest sales dollars to lowest:
Drug Sales in billions
Seroquel XR 1.3
Abilify was the number one drug on the Top 100 list for highest sales overall. This is the most expensive antipsychotic drug available. Terminal delirium and related psychoses or agitation experienced by hospice patients may often respond very well to much less expensive antipsychotic drugs such as Haloperidol or Risperidone (about 1/30th and 1/5th the cost of Abilify, respectively).
There were 2 PPI’s (proton-pump inhibitors) on the list; Nexium took the number 2 spot and Dexilant was number 56 on the Top 100. Effective management of gastric distress in hospice patients may often be achieved with the oldest generic PPI, Omeprazole. Omeprazole OTC is about 1/15th the cost of these two brand name PPI’s.
Advair and Symbicort are both long-acting beta agonist (LABA) / steroid combination inhaler drugs which are dosed twice daily. Both are expensive. There are no low cost LABA/Steroid combination products currently available. One option for low-cost alternative therapy in hospice is to use the short-acting beta-agonist, Albuterol (four times daily), plus an oral steroid such as Prednisone 5 - 10mg daily. Long term use of oral steroids is associated with higher incidence of side effects, however, in the hospice setting such long-term use may not be a relevant concern. The Albuterol plus Prednisone option would be about 1/10th the cost of the Advair or Symbicort.
Two other inhaled respiratory medications on the list were Spiriva and Combivent metered dose inhalers (MDI’S). Spiriva is an anticholinergic-type bronchodilator (tiotropium) and Combivent is the combination of the anticholinergic bronchodilator, Ipratropium, and the beta-agonist bronchodilator, Albuterol. While there is no low cost alternative to these products in metered-dose-inhaler (MDI) dosage form, there is a good low cost alternative in the nebulizer solution dosage-form of the albuterol-ipratropium combination product, also known as Duoneb (about ½ the cost of Spiriva or Combivent therapy).
Lyrica is used for both seizure management and control of neuropathic pain in hospice patients. A reasonable cost-effective alternative is Gabapentin which is about 1/4th the cost of Lyrica in equivalent doses.
Oxycontin is one of the most expensive long-acting opioids available. Methadone is a very effective alternative at about 1/30th the cost for an equivalent dose. Methadone also has the advantage of being available in a liquid dosage-form for those patients who have difficulty swallowing whole tablets. Oxycontin tablets should not be crushed. Morphine Extended Release tablets may also be a reasonable alternative at about 1/3 the cost of Oxycontin. Like Oxycontin, the morphine extended release tablets should not be crushed.
Celebrex is a Cox-2 selective non-steroidal anti-inflammatory (NSAID). This is the only cox- 2 selective NSAID currently available and therefore has a distinct advantage in patients where there is significant concern or history of NSAID induced gastric side effects. Alternatives for patients that are not in that category would in include Naproxen, Ibuprofen, and Meloxicam. These options are all about 1/10th the cost of Celebrex in equivalent doses.
Namenda may be effective for management of cognitive symptoms encountered in moderate to severe dementia. There is no evidence that this drug has any significant benefits in “end-stage” dementia, classified as Level 7a or greater using the FAST rating scale. By definition, a patient with a hospice diagnosis of dementia would be at Level 7a or greater, so continued therapy with Namenda would not be recommended once the patient is admitted to hospice with this diagnosis.
Seroquel XR is the extended-release (once daily) version of the antipsychotic drug, quetiapine immediate release (twice daily). Quetiapine immediate release is available as a generic and is less expensive than the XR form with only minimal adjustment for dosage compliance (one dose per day vs two). An even more cost-effective option is Haloperidol which is about 1/12th the cost of generic quetiapine in equivalent doses.
Lunesta is a sedative-hypnotic which is used for management of insomnia in hospice patients. Lunesta has recently gone generic (Eszopiclone), however, even that version is still pricey. There are a couple of cost-effective alternatives: Temazepam (a benzodiazepine sedative hypnotic) and Trazodone (a sedating antidepressant). Trazodone and Temazepam have been used extensively in hospice for managing insomnia with good results. Both of these alternatives are about 1/15th the cost of Eszopiclone.
Conclusion: The cost-effective alternatives discussed in this article may not be appropriate for all hospice patients, and consideration of the individual patient’s drug history and comorbid conditions need to be factored into any decision to change medications. On the other hand, each of the alternative medications suggested here have been widely used in hospice and palliative care settings for long periods of time with positive results. While not appropriate for all patients, these alternative medications should be considered as possible first-line therapies for the majority of hospice patients.
For additional information on equivalent doses and corresponding costs, there are some helpful Hospice Medication Charts on the Outcome Resources website that provide detail about inhaled respiratory medications, PPI’s, and benzodiazepines. You can find these under Clinical Resources in the member’s section. Outcome Resources hospice clients can also contact our clinical pharmacist staff for specific recommendations as needed.
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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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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.