The Hospice Clinician Blog

“Drug Shortage Prevention Act” Introduced

We’ve all noticed—and many of us have been directly affected by—the drastic increase in drug shortages over the past few years. The number of drug shortages has quadrupled since 2005, with the American Society of Health-Systems Pharmacists (ASHP) website currently listing 216 drugs that are in short supply. Injectable medications make up the majority of the list (examples include injectable diazepam, fentanyl, haloperidol, and midazolam), but other routes of administration are affected as well (such as ciprofloxacin tablets, diclofenac gel, nystatin oral suspention and scopolamine transdermal patches). Many of the medications on the list are ones commonly used in hospice and palliative care.

On January 31^st, U.S. Representatives John Carney (D-DE) and Larry Bucshon (R-IN) introduced the bipartisan “Drug Shortage Prevention Act”, which is the latest action plan to address the increasing problem of drug shortages. According to its sponsors, the bill “brings more efficiency to the manufacturing and distribution processes and requires the FDA to take action to prevent drug shortage problems before they begin impacting patients.”

The Drug Shortage Prevention Act would:

• Require the FDA to identify drugs that are vulnerable to shortages through the creation of a “Critical Drug List” and “Critical Drug Shortage List.” The agency would determine the standards of what constitutes a “critical drug” and “critical drug shortage.”
• Require the FDA to expedite review of: applications seeking approval of a “critical drug”, requests to approve changes to manufacturing processes or facilities of drugs in shortage, and applications for an alternative active pharmaceutical ingredient supplier.
• Attempt to cut down on the “gray market” by requiring the FDA to notify distributors of an imminent critical drug shortage, while also allowing the agency to withhold notification to a distributor determined by the Attorney General to be stockpiling, price gouging or engaging in other unlawful activities related to distribution of a drug in shortage.
• Require the FDA to develop a system to notify members of the public—including providers and patients—when a drug is added to the drug shortage list.
• Mandate closer and more expedient internal communications between FDA's regulatory staff and its drug shortage team.
• Allow the Attorney General to determine whether it is appropriate to increase one or more DEA quotas to address a drug shortage, and mandate that DEA, in consultation with FDA, increase the quota for controlled substances on the shortage list to address a shortage.
• Require the Secretary of Health and Human Services to conduct a feasibility study to determine the efficacy and logistics associated with creating a national contingency plan in the event of a critical drug shortage, including the creation of a national stockpile for these drugs.

The topic of drug shortages is expected to be raised next week at a House Energy and Commerce Committee hearing.

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Medication Reviews and Medicare CoPs: Is Your Hospice in Compliance?

The Medicare hospice Conditions of Participation (CoPs) are the federal regulations that govern all Medicare-certified hospice programs, and contain the health and safety requirements that all hospices are required to meet. In section 418.54, the CoPs specify standards for a “comprehensive assessment” that must be conducted by the hospice interdisciplinary group (IDG). The comprehensive assessment must take into consideration, among other things, the patient’s medication profile, including “a review of all of the patient's prescription and over-the-counter drugs, herbal remedies and other alternative treatments that could affect drug therapy.” There are three main requirements related to the medication review process that hospices should be aware of. According to the Center for Medicare and Medicaid Services (CMS), these requirements comprise three of the top 10 most frequent survey deficiencies cited during Medicare hospice recertification surveys.

1. The CoPs specify that the hospice IDG “must complete the comprehensive assessment no later than 5 calendar days after the election of hospice care” (which is the effective date of the election statement).

2. The drug profile review should include (but is not limited to) an analysis of:

a.  Effectiveness of drug therapy.

b.  Drug side effects.

c.  Actual or potential drug interactions.

d.  Duplicate drug therapy.

e.  Drug therapy currently associated with laboratory monitoring.

The medication review should be completed by an individual with education and training in drug management, such as a pharmacist or physician.

3. The CoPs require that the hospice IDG periodically update the comprehensive assessment “as frequently as the condition of the patient requires, but no less frequently than every 15 days.” Note that the requirement is that the comprehensive assessment be updated, not completely redone. Here, the language is open to interpretation. According to the CMS Interpretive Guidelines (used by surveyors assessing compliance), “The hospice should review each patient’s medications and monitor for medication effectiveness, actual or potential medication-related effects, duplicate drug therapy and untoward interactions during each update to the comprehensive assessment, and as needed as new medications are added or changed, or the patient’s condition changes. Hospices are not required to complete, in full, those documents that they identified as comprising their comprehensive assessment every 15 days, although hospices are free to do so if they so choose. They are required to identify and document if there were no changes in the patient/family condition or needs.” Some hospices choose to have a new medication review performed every 15 days regardless of whether there have been any major changes to the patient’s medication profile or clinical status. Other hospices choose to only perform a new medication review when it is warranted by major changes. Either system would be considered compliant with CoPs.

With all the CoPs, a crucial element is documentation. All assessments should be clearly documented and accessible within the patient’s record.

 

Proper Inhaler Technique in Hospice Patients

In this month’s issue of our newsletter, The Clinician, we shared with you an article entitled “The Medication Management of COPD in Hospice Patients”, which reviewed the treatment of end-stage COPD and discussed rational and effective ways to combine inhaled medications. In the article we emphasized the importance of proper inhaler technique in delivering safe and effective medication doses. When patients don’t use their inhalers properly, they don’t benefit from them as much as they should, and may be more susceptible to certain side effects (such as thrush, which can occur when inhaled corticosteroids deposit in the mouth instead of in the lungs).

As hospice care providers, we should know exactly how inhalers should be used so that we are able to assess and educate our patients in proper inhaler technique. This can be quite challenging when each inhaler has its own specific instructions. So, as promised in the newsletter article, what we are providing here are inhaler-specific usage instructions. These can be downloaded and printed for nurses, patients, caregivers, or anyone who would like instructions on proper inhaler technique. Simply click on the name of the inhaler to download the usage instructions.

This list includes all brand-name metered dose inhalers (MDIs) and dry powder inhalers (DPIs). It does not include nebulized medications, since all nebulized medications are used in essentially the same way, and instructions will depend more upon the type of nebulizer than on the medication being used.

If you would like a copy of “The Medication Management of COPD in Hospice Patients”, please contact us!

Advair Diskus

Advair HFA

Alvesco

Arcapta Neohaler

Asmanex Twisthaler

Atrovent HFA

Combivent

Dulera

Flovent Diskus

Flovent HFA

Foradil Aerolizer

Maxair Autohaler

ProAir HFA

Proventil HFA

Pulmicort Flexhaler

Qvar

Serevent Diskus

Spiriva

Symbicort

Ventolin HFA

Xopenex HFA

Update on Immediate-Release Fentanyl REMS

In a step towards simplifying opioid Risk Evaluation and Mitigation Strategies (REMS), the FDA has approved a single, shared system REMS for the whole class of transmucosal immediate-release fentanyl (TIRF) drugs. The shared REMS system, called the TIRF REMS Access Program, will replace individual REMS for these agents, allowing prescribers and pharmacies to enroll into a single system. This is the first approved class REMS for any opioid drugs.

TIRF opioid agents include Abstral (sublingual tablet), Actiq (oral transmucosal lozenge), Fentora (buccal tablet), Lazanda (nasal spray) and Onsolis (buccal soluble film). The newly approved immediate-release fentanyl product SUBSYS sublingual spray (see the previous blog article) will also fall under the TIRF class REMS.

With the exception of SUBSYS, all of these products currently fall under individual REMS, with the exception of Fentora and Actiq, which are combined into one. That gives a total of 4 separate REMS in which prescribers, pharmacies and patients must enroll to be able to use these medications. When the new TIRF REMS Access Program launches in March of this year, there will be only one program in which healthcare providers and patients will have to enroll to use any TIRF product. This will ease some of the burden on the healthcare team, and will allow prescribers to decide which product is best for their patient without having to be concerned about which program they, or their patient, are enrolled in.

Until the TIRF REMS Access Program launches in March, the FDA has instructed that prescribers, patients, and pharmacies continue to enroll in the individual REMS programs. Then, prescribers and pharmacies already enrolled in an individual REMS program for at least 1 TIRF medication will automatically be transitioned to the shared TIRF REMS Access Program. Prescribers not yet enrolled in any TIRF REMS can enroll in the new program by reviewing an education program, successfully completing a knowledge assessment, and completing an enrollment form. All of this, and additional information about the enrollment process, will be available on the TIRF REMS Access Program website when the program launches in March.

The TIRF REMS Access Program will only apply to TIRF medications used on an outpatient basis. Healthcare professionals who prescribe TIRF medications that will only be used in an inpatient setting, including hospitals, hospices, or long-term care facilities, will not be required to enroll in the TIRF REMS Access Program, nor will patients who receive TIRF medications in an inpatient setting.

 

Hospice Medication Alert: New Fentanyl Sublingual Spray Approved

INSYS Therapeutics has announced FDA approval of SUBSYS fentanyl sublingual spray for the treatment of breakthrough cancer pain. SUBSYS is a single-dose sublingually-administered formulation of fentanyl that joins five other rapid-acting fentanyl products already on the market (Abstral, Actiq, Fentora, Lazanda and Onsolis). INSYS Therapeutics claims SUBSYS is the only transmucosal fentanyl product to show statistically significant pain relief when measuring the sum of pain intensity difference at five minutes in a Phase 3 clinical trial of breakthrough cancer pain.

SUBSYS will be launched under the recently approved Transmucosal Immediate-Release Fentanyl (TIRF) REMS Access Program, which we will be discussing further on the blog next week. SUBSYS is expected to be available in the early part of this year.

Attention Hospice Providers: Important Public Health Advisory

The FDA is advising healthcare professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site. Due to problems that occurred when these products were packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product. This could result in a stray pill of one medicine ending up in the bottle of another product. 

 

The following products may be affected:

 

• Opana ER (oxymorphone extended-release)
• Opana (oxymorphone immediate-release)
• Oxymorphone (generic)
• Percocet (oxycodone/acetaminophen)
• Percodan (oxycodone/aspirin)
• Endocet (oxycodone/acetaminophen)
• Endodan (oxycodone/aspirin)
• Morphine sulfate extended-release (generic)
• Zydone (hydrocodone/acetaminophen)

 

The FDA advises patients and healthcare professionals to examine opiate medicines made by Endo in their possession and ensure that all tablets are the same. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Go to http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm to learn how to report.

Hospice Medication Alert: Washington State Warns on Methadone Use

The state of Washington will soon issue an unprecedented public health advisory that highlights the risks of methadone. This warning has been approved and adopted by a committee of state-appointed medical experts following an investigative newspaper story in the Seattle Times (see link below) which captured the attention of the state legislature. The Times claims that a review of death certificates in the state over the past 8 years  turned up 443 cases in which methadone was listed as the sole drug in fatal overdose cases (about 55 cases per year).  In addition the newspaper story states that methadone may have somehow been linked to over 2,100 fatal drug over-doses in that same 8 year period from 2003 to 2011. The Times story indicated that Washington's methadone death rate ranks among the country's highest. The story did not specify how many of these fatal overdose cases were situations where the individual was abusing the drug or if they were all patients with a legitimate prescription for the medication.  

The health advisory will stress that methadone can be more unpredictable than other analgesics, including other opioids. It will be sent to pharmacies as well as licensed health care professionals throughout the state.  

Methadone is unique in a number of areas when compared to other opioids. The unique differences offer very significant benefits as well as challenges to managing toxicity risk. If Washington’s efforts result in an increased awareness among physicians, nurses, and pharmacists of these issues leading to more appropriate methadone prescribing and follow-up, then this public health advisory can be the start of something quite  positive.  On the other hand, if the state’s initiative is designed to label methadone as a medication that is too dangerous to use in patients with severe chronic pain, then everyone in the state loses.  

Methadone has a bi-phasic nature when it comes to duration of analgesic effect. When methadone is initiated ,the duration of analgesic effect is about 4 to 6 hours at the most.   After continuous routine use for about five days, the drug exerts a more long-acting duration of approximately 12 hours in a majority of patients. The reason behind this is the fact that methadone is both highly lipid soluble and has a very large volume of distribution in the body.   These characteristics result in the drug accumulating in the body (upon continued use) and forming a kind of depot that creates the long-duration of analgesia, which is not seen during the initial few days of therapy. This is very different from other opioids. This concept must be understood and incorporated into the prescribing and monitoring practices whenever methadone is used.

There is also a wider degree of inter-patient variation in response to methadone than may be seen with some other opioids. Some patients may reach the “depot” stage with only 3 days of methadone dosing , while others may take 7 or 8 days. Attentive monitoring of the patient during this accumulation phase is essential. There will also be varying levels of cross-tolerance exhibited when converting from other opioids to methadone. This level of cross-tolerance will vary depending upon the dose of the opioid that one will be converting from. Generally, the higher the dose of opioid, the less cross-tolerance to methadone will be encountered. The practitioner should generally use lower equivalent dosages of methadone for patients on higher doses of other opioids to avoid inadvertent over dosage.  Successful methadone dosing may be challenging, however, methadone has been used extensively with very high success rates in numerous palliative care and hospice settings over the past decade.    It may be that practitioners in these settings have more experience and a greater appreciation for the unique pharmacokinetics of the drug than some others practicing in the general community.

The advantages of methadone are widely recognized and include the following:

• Effective where other opioids fail, such as in neuropathic pain
• Available in a variety of dosage-forms  that allow for administration to patients with swallowing difficulties (tablets that may be crushed, oral concentrate solution 10mg/ml)
• Methadone is absorbed well by the sublingual route (for patients that can’t swallow at all)
• The solution form is long-acting just like the tablets
• Very low cost.     Methadone is about  1/20 to 1/40  the cost of other long-acting opioids

The risks for methadone toxicity due to unexpected drug accumulation or incorrect conversion doses can be managed effectively when the practitioners understand the unique pharmacodynamics of methadone and follow appropriate prescribing and monitoring practices. 

The current issue with methadone toxicity addressed in the Times article and subsequently discussed within the Washington state legislature may boil down to a lack of education regarding this unique drug.  Physicians, nurses, and pharmacists all need to have a clear understanding of methadone pharmacokinetics before prescribing, dispensing, or caring for a patient on methadone.  This drug offers significant therapeutic benefits and unparalleled value over other long-acting strong opioids.  It would be very unfortunate if the actions of Washington state result in the denial of methadone availability for the patients suffering from severe chronic pain. On the other hand, this represents a great opportunity to promote and disseminate appropriate information to a wide range of health-care professionals regarding the effective use of methadone for those with chronic severe pain.  

See the Original Article on Methadone in The Seattle Times

 

Outcome Resources offers all of our hospice clients education and consultations to assist with the effective and safe use of methadone for their hospice patients. If you are interested in learning more about how we help hospices succeed, Contact Us.

 

 

 

Hospice Medication Update: Morphine/Oxycodone Combination Product (MoxDuo® IR) Expected in 2012

A few months back, we informed you of a new product that was moving closer to FDA approval: a combination product containing immediate-release morphine and immediate-release oxycodone in a 3:2 ratio called MoxDuo® IR. Now, generic manufacturer Actavis has partnered with QRxPharma and has announced their intention to launch MoxDuo® IR in the third quarter of 2012.

The New Drug Application submitted to the FDA includes results from three pivotal Phase 3 studies for the treatment of moderate to severe post-operative pain. In head-to-head comparisons with morphine, oxycodone, Percocet and placebo, more than 700 patients have been treated with MoxDuo® IR in seven clinical trials. Clinical data have consistently demonstrated that MoxDuo® IR achieves equal or better pain relief with fewer incidences of moderate to severe side effects, notably a clinically significant reduction in respiratory depression.

MoxDuo® IR is part of a larger dual opioid portfolio including intravenous (MoxDuo® IV) and controlled release (MoxDuo® CR) formulations. These formulations are designed to incorporate tamper resistance and reduced abuse liability as appropriate.

Study Suggests Synergism Between Medical Marijuana and Opiates

In a paper published this month in Clinical Pharmacology & Therapeutics, researchers from UCSF examined the interaction between cannabinoids (the main ingredient in medical marijuana) and opiates in the first human study of its kind. They found the combination of the two components reduced pain more than using opiates alone, similar to results previously found in animal studies.

The primary endpoint of this small-scale study (21 patients) was to determine whether the use of medical marijuana would increase, decrease, or have no effect upon plasma levels of morphine and oxycodone in patients taking these opioids routinely for chronic pain. Of the 21 patients, 10 were taking extended-release morphine and 11 were taking extended-release oxycodone. After obtaining opiate blood levels at the start of the study, the patients inhaled a controlled amount of vaporized cannabis three times daily for four consecutive days. On the fifth day, they again measured opiate blood levels. In the process, researchers also asked patients about their pain relief. What they found was surprising.

On day 5, blood levels of morphine were slightly lower than they had been at the start of the study, and the levels of oxycodone were unchanged. However, the morphine group experienced a statistically significant reduction in average pain score from 35 to 24 (33% reduction), and the oxycodone group’s average pain score dropped from 44 to 34 (20% reduction). Patients did not experience any major side effects. Researchers concluded that vaporized cannabis augments the analgesic effects of opioids without significantly altering plasma opioid levels. The combination may allow for opioid treatment at lower doses with fewer side effects—which would benefit many of our hospice patients.

These results are only a first step toward understanding the role of medical marijuana in the treatment of chronic pain. According to Donald Abrams, MD, the paper’s lead author, “What we need to do now is look at pain as the primary endpoint of a larger trial,” he said. “Particularly I would be interested in looking at the effect of different strains of cannabis.”

Marijuana contains about 70 compounds which have different effects. Delta-9 tetrahydrocannabinol (Delta-9 THC) is the main psychoactive component, responsible for the “high” associated with marijuana. As the active ingredient in the drug dronabinol (Marinol®), delta-9 THC helps treat chemotherapy-induced nausea/vomiting and stimulate appetite, but it has only mild pain-relieving properties. It also has potential side effects such as tachycardia, confusion, anxiety and paranoia. Cannabidiol (CBD) is a major, non-psychoactive component of cannabis that helps reduce pain and inflammation without inducing euphoria.

“I think it would be interesting to do a larger study comparing high THC versus high CBD cannabis strains in association with opiates in patients with chronic pain and perhaps even having a placebo as a control,” Abrams said. “That would be the next step.”

Reference:                                                                                    

Abrams DI, Couey P, Shade SB, Kelly ME, Benowitz NL. Cannabinoid-Opioid Interaction in Chronic Pain. Clinical Pharmacology & Therapeutics 2011; 90: 844-851.

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