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Hospice Medication Alert: New Parkinson's Disease Medication

Jim Joyner, PharmD, CGP

Rytary is the brand name for a new formulation of “extended-release” carbidopa-levodopa that has recently become available in the U.S. in capsule form.  It is indicated for the treatment of mild to moderate to severe Parkinson’s disease.  Clinical trials with this new formulation were conducted comparing Rytary with immediate-release carbidopa-levodopa tablets.  The study results indicated significant improvements in a patient’s ability to move and perform activities of daily living, as well as experiencing significantly more “on” time and less “off” time without dyskinesia.   There are currently no published studies comparing Rytary with the “controlled-release” carbidopa-levodopa tablet (originally Sinemet CR, although generics are now available).  The Sinemet CR tablet is formulated as an erodible polymer matrix that slows the release of medication from the tablet. The Rytary capsule contains both immediate-release and extended-release beads.  Clinically significant differences in patient response to these two “extended-release” products should be anticipated because of the difference in formulation.   

“Controlled or “extended” release carbidopa-levodopa preparations have been formulated in attempts to achieve a steadier climb to peak plasma concentrations that are less extreme and provide greater duration of anti-Parkinson effects.   Both Rytary and the older Sinemet CR tablet are formulated to achieve this objective, but use different technology to control dissolution rates.  Both dosage forms have been shown to provide more “on” time, less “off” time, and less dyskinesia for Parkinson’s patients than the immediate-release tablets.   It remains to be seen how much of an advantage, if any, the new extended-release capsule (Rytary) has over the older extended-release tablet (Sinemet CR).  

Rytary is not a generic equivalent to either the immediate release, nor the controlled release carbidopa-levodopa.  The manufacturer provides a conversion table for guidance on converting from carbidopa-levodopa immediate release to Rytary.   

Available combination strengths of Rytary Extended Release Capsules are as follows:  23.75mg/95mg, 36.25mg/145mg, 48.75mg/195mg, and 61.25mg/245mg.  

The starting dose for Rytary in levodopa naïve patients is 23.75mg/95mg three times per day for 3 days. On day 4, the dose may be increased to 36.25mg/145mg three times daily.   Further dosage increases may be employed based upon patient response, up to a maximum recommended dose of 97.5mg/390mg three times a day.   Capsules should be swallowed whole and should not be chewed or crushed.   For patients that cannot swallow capsules whole, Rytary capsules may be opened and the contents can be sprinkled on to a small amount of applesauce for immediate consumption.

Most common adverse effects noted with Rytary were nausea and headache (similar to immediate release carbidopa-levodopa in the comparison trial).  

Rytary may offer a significant advantage in Parkinson’s patients who are not able to achieve adequate periods of “on” time during the waking hours, or those who exhibit troublesome dyskinesia with carbidopa-levodopa immediate-release tablets.   There is currently no data available to demonstrate any clinical advantage of Rytary over the carbidopa-levodopa CR (controlled release) tablets.  From a practical standpoint, Rytary does have an advantage over the “CR tablets” for patients that cannot swallow whole pills, since the carbidopa-levodopa tablets should be swallowed whole and should not be chewed or crushed.   As with most new products, Rytary is expensive with a mid-range dosage expected to cost the hospice between $300 - $400 per month.  


More information:


National Prescription Drug Take-Back Initiative

Jennifer Chen, PharmD

DEA has announced that the 10th annual National Prescription Drug Take-Back will take place on September 26th from 10am to 2pm local time in every state except Pennsylvania and Delaware, where it will take place on September 12th. This is a great opportunity for the public to dispose unwanted and expired medications. These types of medications in the house are a leading cause of accidental poisoning. In addition, inappropriate disposable of medications may also lead to potential safety and health hazards. Check your own medicine cabinets and advise your patients, friends and families. Help get those drugs out of homes and reduce the threat of prescription drug abuse.

Click here to find a DEA collection site near you!

What should you do if you miss this event?

Another option for long-term care facilities to dispose of unwanted medications is to transfer those medicines to collectors registered with the DEA. These DEA-authorized collectors safely and securely collect and dispose of pharmaceuticals containing controlled substances and other medicines. In your community, authorized collection sites may be retail pharmacies or hospital pharmacies. These sites may also offer mail-back programs or collection receptacles (or “drop-boxes”) to assist the public in safely disposing of medications. Click here to locate a DEA-authorized collector in your area.

If there is no take-back program or DEA-authorized collectors available in your area, you may also dispose of medicines in household trash or flush certain medicines down the toilet (be sure to know the law in your state before recommending medications to be flushed; for example, flushing medications down the toilet is not recommended in California). The FDA provides an updated list on the drugs recommended for disposal by flushing (last updated in February 2015). For more information on proper drug disposal, please review our previous blog posts on the topic of proper drug disposal.


New Hospice Medication Alert: Another Anti-Clotting Drug Savaysa (edoxaban)

Esther Liu, PharmD, MSIA, CGP

The U.S. Food and Drug Administration (FDA) approved another anti-clotting drug Savaysa (edoxaban) in January 2015 for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). This medication also has the FDA approved indication to reduce the risk of stroke and blood clots in patients with atrial fibrillation, but it is not recommended for patients with CrCl greater than 95ml/minutes due to its inferior efficacy in comparison to Coumadin (warfarin) at clinical trials.

This is the third oral factor Xa inhibitors approved by FDA as an anticoagulant to treat blood clots and prevent stroke risk in the last four years. The most common side effects for Savaysa observed in clinical trial participants were bleeding and anemia.(1) Just like the other FDA-approved anti-clotting drugs, bleeding, including life-threatening bleeding, is the most serious risk with Savaysa. There is no treatment that has been proven to reverse the anticoagulant effect of Savaysa like the antidote we have for Coumadin.

Factor Xa inhibitors, like Savaysa, are likely to be reserved as a second line therapy due to its lack of antidote to the anticoagulant effect and they are cost-prohibitive compared to Coumadin. When you encounter a patient with one of the new anticoagulants in the hospice setting, it is important to ask the following questions to ensure if the anticoagulation treatment is still suitable for your hospice patients:

1. Is the patient taking the medication for treatment or stroke prevention?

If the patient is taking the medication for stroke prevention in atrial fibrillation, the medication should be considered for discontinuation unless the patient has a high risk for clotting. Outcome Resources provides patient-directed letters to help hospice providers to communicate the rationale of discontinuing the anticoagulant at end of life care.

2. What is the risk vs. benefit of continuing the anticoagulation therapy? What is the likelihood of patient getting another blood clot? Did the patient have a recent clotting event even if the patient is using the medication for clotting prevention?

A study has suggested that anti-coagulants can reduce stroke risk by about 4% per year on average for ambulatory patients with atrial fibrillation.(2) Hospice patients are more likely to suffer from the side effects of bleeding at end of life than having a blood clot event. Therefore, the risks of anticoagulation treatment are greater than the benefits in this population and should be considered for discontinuation.

3. If the hospice patient has a high risk for clotting and has a reasonable functional level (Palliative Performance Scale >40%), why is the patient not able to take Coumadin (warfarin) versus the other anticoagulants?

Coumadin is the most cost-effective medication in the class of anticoagulants even after taking into account for the INR monitoring cost. It is the only oral medication in this class with an antidote for its anticoagulation effects, which makes it a safer option for patients with bleeding risk, especially in the hospice setting. The only drawback to using Coumadin is the requirement of routine INR monitoring on the anticoagulation effect while the newer agents do not. However, recent studies have suggested that routine INR monitoring improves patient adherence to the anticoagulant therapy, which leads to better outcomes from Coumadin in general.(3)   

If you have asked these three sets of questions above and the answers still suggested that the patient is a candidate to continue on an anticoagulation therapy, then you can consider some of the newer oral agents, like the factor Xa inhibitors. They are generally more cost-effective than the injectable anti-coagulants like Lovenox.

Here is the clinical pearl of using anticoagulants in hospice setting. 1) Consider discontinuation if possible. 2) If not, Coumadin remains as the gold standard to treat/prevent blood clots before other newer anticoagulants. 3) Reserve the injectable anticoagulants as the last resort as it is both invasive and expensive. 

View a Comparison Chart of Oral Anti-Coagulants



1. FDA approves anti-clotting drug Savaysa: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm429523.htm . Accessed August 27, 2015.

2. Archives of Internal Medicine 1994; 54: 1449-1457.

3. Comparing the New Oral Anticoagulants. Pharmacist’s Letter. June 2014.

4. Anticoagulant Comparison Chart. North American Thrombosis Forum. www.natfonline.org. Accessed August 27, 2015

More information:


Hospice Medication Alert: Allergan Recalls Contaminated Eye Ointments

Jennifer Chen, PharmD

On 8/25/2015, Allergan has issued a voluntary nationwide recall on certain lots of various eye ointments due to contamination of black particle from unscrewing the cap from the aluminum tube. This black particle can potentially be introduced into the product and was found at time of use by a small number of customer. The reported adverse events include foreign body in the eye, superficial eye injury, pain, swelling and blurred vision.

Two of recalled ointments are sold over the counter. The ointments in question are:

  • Refresh Lacri-Lube 3.5g and 7g for dry eye - OTC
  • Refresh P.M. 3.5g for dry eye - OTC
  • FML (fluorometholone ophthalmic ointment) 0.1%, 3.5g for eye inflammatory conditions – RX only
  • Blephamide (sulfacetamide-prednisoone) 10%-2%, 3.5g – this is a combination of antibiotic and a corticosteroid usually used for infection, RX only.

This recall only applies to specific lots of the product listed above and does not affect any other Refresh or Allergan product. Specific information on product and lots can be found by clicking here. The lots subject to the recall have expiration dates that range from April 2017 to March 2018. This recall is extended to the patient level, so the pharmacies which have dispensed these products may have already contacted the patients who may have received these products. As an additional precaution, it is advised to check with your patients who are currently using these eye ointments and evaluate if they are affected by this recall. 

More information:


Hospice Medication Alert: Hydrochlorothiazide 25mg Tablet Recall

Stephanie Cheng, PharmD, MPH

On 07/30/2015, Unichem Pharmaceuticals issued a voluntary recall of a specific lot of their Hydrochlorothiazide 25mg tablets as a Plavix (clopidogrel) tablet was found in a bottle of the product. The FDA has notified distributors and pharmacies about the recall.  The dispensing pharmacies were expected to identify patients received the specific lot of medication and to bring this to the attention of the consumer level. Unichem has stated that this episode is an isolated event noted at one pharmacy and confined to the recalled lot.  They have not received any reports of adverse events related to this recall to date.


The risk of mistakenly taking a Clopidogrel tablet instead of a Hydrochlorothiazide tablet may include an increased risk of side effects associated with Clopidogrel, which include bleeding and/or bruising. Patients with active bleeding or who are allergic to Clopidogrel or any component of the formulation may experience more serious adverse health consequences as a result of unknowingly consuming Clopidogrel. Additionally, missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema).

The affected Hydrochlorothiazide 25mg lot is GHYL15028 – expiration April 2018. It was packaged in 1000-count bottles and were distributed nationwide directly to wholesalers, retailers and pharmacies from May 21 - 28, 2015.  The tablets can be identified as a round light orange/yellow tablet with a beveled edge, with a score mark and U 128 imprint.

There is a “drug identifier tool” under Clinical Resources in the members section of our web-site:  www.OutcomeResources.com.   You may identify a pill by entering the shape, color, imprint, dosage-form, or scoring on a tablet.  This may be very helpful when loose pills are found in the patient’s home or in cases such as this when different tablets are found in the same prescription bottle.  

Outcome Resources is including this information on our blog for the hospice clinicians since Hydrochlorothiazide 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 Hydrochlorothiazide 25mg 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 dispensing pharmacy to verify the lot information for you.  In the event you encounter the recalled product, return it to the pharmacy that dispensed it for a replacement.

If you are an Outcome Resources client, the clinical team will reach out to you if we have suspected that one of your patients has received Hydrochlorothiazide from this manufacturer.

More information:


A Comparison of Inhaler Devices & The Use of Inhalers in the Hospice Setting

Jennifer Chen, PharmD

A variety of new medications and combination treatments along with novel delivery devices are in development to help patients with COPD achieve improved symptom control and a better quality of life. This article will discuss different inhalation delivery devices currently available in the market (pMDI, DPI and Soft Mist Inhaler) and their limitations for hospice patients.

Types of inhalers

pMDI (pressurized metered dose inhaler) is the most commonly used device. The drug is dissolved in the propellant called hydrofluoroalkanes (HFAs) under pressure. The system releases a metered volume of propellant containing the medication. It requires a high degree of hand-breath coordination for effective treatment, which is the major disadvantage of pMDI. These devices deliver the medication at a high velocity which may result in some of the dose being deposited at the back of throat and swallowed instead of actually being inhaled, especially if the inhalation is not timed well with the actuation of the device.  Although a spacer or holding chamber may be used in conjunction with the inhaler to improve drug delivery in patients with poor coordination, this transforms the inhaler into a bulkier device that makes it less portable and more difficult to transport. Some examples of pMDI currently available in the market are Ventolin HFA, Xopenex HFA, Atrovent HFA, QVar, Flovent HFA, Advair HFA and Dulera.

DPI (dry powder inhaler) were developed to help overcome the problems of hand-breath coordination associated with pMDIs. The powdered drug is dispersed into particles by the patient’s own inspiratory effort. The issue of hand-breath coordination is resolved, but the patient must generate adequate inspiratory force to ensure that the medication from a DPI is being delivered to the lungs. This may result in erratic dosage and compromise the consistency in disease control for patients who have inadequate positive inhalation force.  Some examples of DPI currently available in the market are Foradil Aerolizer, Serevent Diskus, Adviar Diskus, Asmanex Twisthaler, and Breo Ellipta.

SMI (Soft Mist Inhaler) generates a soft mist that last longer and delivers higher fine particle fraction than the aerosol cloud, which should lead to improved lung and reduced oropharyngeal deposition versus other types of inhaler. Although the Soft Mist inhaler is not dependent on inspiratory flow rate and has simplified coordination of inhalation and actuation, the device still requires positive inhalation force and some degree of hand-breath synchronization.1 Currently Combivent Respimat, Striverdi Respimat, Spiriva Respimat and Stiolto Respimat are on the market.  

Inhaler technique

Poor inhaler technique is often a main cause of sub-optimal COPD management. In a recent study of 1664 adult patients (mean age 62 years old), critical errors were observed in 12% of patients using a pMDI and 35% of patients using a DPI.2 According to the study, the most common critical errors with MDIs and DPIs are no or short breath-holding after inhalation and failure to achieve a forceful inspiratory flow, respectively. The correct inhalation technique of soft mist inhalers resembles that used with a MDI although the study did not assess the mishandling of SMI.

Use of inhalers in the hospice setting

In general, the use of inhaler devices may be limited in the hospice setting because most end-stage COPD patients do not have effective positive force to inhale medication contents from the device nor able to synchronize actuation with inhalation. Unlike the inhalers, no special inhalation techniques are needed for optimum delivery with conventional nebulizers, which is usually the most effective way to deliver inhaled medications in hospice patients. An inhaler should only be prescribed with the absolute certainty that the patient can use it correctly. Continued and repeated education for both healthcare professionals and patients in correct inhalation technique is essential to ensure optimal COPD management.

Clinical resources

The Clinical Resources section of the Outcome Resources Member's website contains some additional information that may be helpful.  The Clinical Resources section is available to all Outcome Resources hospice clients through the “Member Login”.


  • Inhaled Respiratory Medication Chart:   This chart lists all of the currently available inhaled respiratory medication products grouped according to pharmacologic type & duration of action.   It is an excellent resource to help identify unnecessary therapeutic duplications in the drug regimen.  This chart also contains comparative cost information and common dosages.


  • Inhaler Information & Instructions for use:  This section contains specific detailed instructions for the use of many of the inhaled respiratory metered-dose devices


  1. Dalby R, Spallek M, Voshaar T. A review of the development of Respimat Soft Mist Inhaler. Int J Pharm 2004, 283:1-9.
  2. Melani AS, Bonavia M, Cilenti V, et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med 2011;105(6):930-8.

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Management of Adverse Events of Antipsychotic Medications in Hospice Patients

Jennifer Chen, PharmD

Antipsychotic medications cause four main extrapyramidal symptoms: pseudo-parkinsonism, akathisia, acute dystonia and tardive dyskinesia. (Tardive dyskinesia, tardive dystonia and neuroleptic malignant syndrome associated with prolonged treatment of antipsychotic medications are not typically seen in hospice patients and will not be included in this discussion.)

Acute dystonia involves with spastic contractions of the muscles, most commonly, in the head and neck. It can occur after a single dose of the antipsychotic agent or days after initiating treatment. Acute dystonic reactions can be life threatening if left untreated. Signs and symptoms are often resolved within 10 minutes of using IM or IV benztropine or diphenhydramine.

Akathisia is commonly described as “anxiety” or “agitation” due to the patient’s presentation of inner motor restlessness. Therefore, it can be difficult to differentiate akathisia from psychiatric anxiety and agitation. Although it is more likely with older generation (traditional) agents, it can also be seen with second-generation antipsychotics. Treatment options include: dose reduction, addition of a low-dose beta blocker (propranolol 20-40mg/d) or a low-dose benzodiazepine (lorazepam 0.5mg q12h).

Pseudo-parkinsonism is a reversible syndrome that include extra-pyramidal symptoms (EPS) such as: stiff posture, shuffling gait, masked facial expression and slow pill-rolling finger tremors. It is often dose-related, therefore it is frequently managed by dose reduction. Most patients recover within two months, and often recover within hours or days of reducing the dose. Anticholinergic drugs are best avoided in older patients because they may cause confusion as well as worsening tardive dyskinesia. Anti-parkinsonism medications such as amantadine may be used to treat drug-induced Parkinsonism. However, it is more suitable for younger patients with drug-induced Parkinsonism as they may also cause confusion and sometimes psychosis in older people. Prophylactic anticholinergics (eg. benztropine and trihexyphenidyl) and anti-parkinsonism medications for hospice patients with prior history of EPS and for those treated with relative high doses of antipsychotic drugs are not recommended due to unfavorable risk profile in older patients.

First generation antipsychotics (FGA) such as haloperidol have been thought to cause more EPS than second-generation antipsychotics (SGA). In fact, recent clinical trial has found there was no statistically significant difference between the treatment groups (FGA vs. SGA) in terms of EPS profile.(1) A systematic review and meta-analysis also compared the new generation antipsychotics versus low-potency conventional antipsychotics and have shown that optimum doses of low-potency conventional antipsychotics might not induce more EPS than new generation drugs.(2) EPS is a potential risk for all antipsychotics so early detection and effective management are important to reduce complications. The use of first generation antipsychotics should not be disregarded due to its risk of EPS and in fact, the older class of drugs are usually associated with better outcomes and lower costs.


  1. Peluso MJ, Lewis SW, Barnes TR, Jones PB. Extrapyramidal motor side-effects of first-and second-generation antipsychotic drugs. Br J Psychiatry. 2012 May;200(5):387-92.
  2. Leucht S, Wahlbeck K, Hamann J, Kissling W. New generation antipsychotics versus low-potency conventional antipsychotics: a systematic review and meta-analysis. Lancet. 2003;361(9369):1581–1589.


Haloperidol Use for Hospice Patients in the Nursing Facility

Jim Joyner, PharmD, CGP

Haloperidol (Haldol) is one of the most useful medications in the hospice setting. It is classified as an antipsychotic drug and is widely used to help manage psychotic symptoms and agitated states resulting from a variety of conditions during end-of-life care in hospice patients. In addition to the psychotropic activity, it is very effective for controlling nausea and vomiting, especially nausea-vomiting that is induced by opioids. Haloperidol is available in a variety of dosage forms including crushable oral tablets, oral concentrated solution (2mg/ml) which may be given sublingual, and a sterile solution for IM or IV injection. These various dosage forms are very advantageous for compromised hospice patients who can no longer take traditional oral tablets due to lack of adequate swallowing ability or severe nausea. 

Unfortunately, many hospices have experienced resistance from administrators and directors when they attempt to use Haloperidol during end-of-life care for their patients who reside in skilled nursing facilities (SNFs). In some cases, this resistance has risen to the level of threatening to completely derail the relationship between the hospice and the SNF. Reasons for the resistance often do not have anything to do with quality of patient care, but are driven primarily by fear of deficiency reports and related fines which might be levied upon the SNF by State and Federal licensing agencies citing the inappropriate use of this drug.   

Haloperidol is an antipsychotic drug. The Centers for Medicare and Medicaid (CMS) have developed very strict standards governing the use of all antipsychotic drugs in patients who reside in the skilled nursing facilities.  These standards are backed with the force of regulation and licensing survey teams may assess deficiency notices and fines with regard to perceived inappropriate use of these antipsychotic medications in the SNF.(1)  The regulatory measures were developed in response to past history of abusive practices at some SNFs where antipsychotics were used inappropriately to “chemically restrain” patients and not as a part of coordinated clinically acceptable intervention to manage their condition.  Current regulations have been drafted with the intent to ensure that antipsychotic drugs are used to treat a specific documented condition for which the medication helps to maintain the patient’s highest practicable mental, physical, and psychosocial well-being in collaboration with the attending physician and facility staff. This includes the administration of the lowest effective dosage, for a duration that is clinically indicated to treat the patient’s specific condition, and appropriate non-pharmacological interventions are considered as a part of therapy along with the antipsychotic drug. Periodic tapering of doses and trials of discontinuation are also recommended as a part of the detailed regulatory guidance for this class of drugs. Close monitoring of patient behaviors and possible adverse effects is required along with detailed documentation of all observations related to the monitoring.   

SNF compliance with these regulations can be daunting considering the level of documentation required as well as the highly subjective way in which many of the licensing survey teams interpret the regulations and apply them to individual patients. This is why many SNF administrators and directors of nursing may view antipsychotic medications, and Haloperidol specifically, as high risk to their organization. For this reason, most SNFs will attempt to limit antipsychotic utilization as much as possible.  

These regulations were created with the intent to guide antipsychotic utilization in the SNF patient suffering from one of the various forms of dementia or otherwise unspecified agitation. For this reason, specific exceptions were written into the surveyor guidance regarding intent of the regulation. The exceptions preclude requirements normally imposed on the use of these medications in the SNF. One of these exceptions is the use of antipsychotic drugs for “adjunctive therapy at end of life,” and another exception is for “nausea and vomiting associated with cancer or cancer chemotherapy”. This is exactly the case when Haloperidol (or other antipsychotics) are used for a hospice patient in the SNF. Unfortunately, many practitioners as well as some licensing surveyors are not well versed on the distinction between these exceptions for hospice patients and other non-hospice SNF patients.  Hospice directors and administrators can take a lead role by being pro-active and discussing this issue with their counter parts at the SNFs to help correct the misconceptions.  

Haloperidol is sometimes singled out as the major offender of this regulatory scenario since it is one of the older classes of antipsychotic drugs commonly referred to as “traditional” antipsychotics.  The newer generation of antipsychotic drugs such as Quetiapine (Seroquel) or Risperidone (Risperdal) are commonly referred to as “atypical” antipsychotic drugs since they tend to be more effective for certain types of atypical psychoses associated with catatonia. The older, traditional antipsychotic drugs may have a greater risk for inducing involuntary movement disorders (parkinsonism, tardive dyskinesia, etc.) than the newer atypicals in general. For this reason Haloperidol is sometimes perceived to be a greater risk to SNF patients than the newer generation antipsychotic drugs. This may be true at high doses, however, at daily doses of 5mg or less (commonly used), haloperidol is tolerated just as well as the newer generation antipsychotic drugs. (2,3) In addition, much of the involuntary movement disorder risk is associated with longer durations of therapy of 3 to 6 months, or more. Such long durations of therapy are unusual for hospice patients.  

It was never the intent of the SNF regulations to restrict the use of antipsychotic drugs, including Haloperidol, for use in managing end-of-life symptoms in hospice patients.  Unfortunately, the distinction between end-of-life care and care for other nursing home residents has become blurred in many instances resulting in the denial of an extremely useful medication for dying patients.  


1. Federal regulation (Centers for Medicare & Medicaid Services – Skilled Nursing Facilities)

F-329; 483.25(l) Unnecessary Drugs, subsection 2. Antipsychotic Drugs

2. Parellada,et al. Risperidone in the Treatment of Patients with Delirium

J. ClinPsychiatry2004;65:348-53. 16

3. Han, et al. A Double Blind Trial of Risperidone and Haloperidol for the

Treatment of Delirium.

Psychosomatics2004:45(4): 297-301


Atropine Sulfate Ophthalmic Solution Shortage and its Implications to Hospice Practice

Esther Liu, PharmD, MSIA, CGP

As of April 20th, 2015, the American Society of Health-System Pharmacist (ASHP) has officially announced that there is a shortage of atropine ophthalmic solution.

Atropine was one of the U.S. Food and Drug Administration (FDA) grandfathered medications originally marketed before 1938 which was prior to current requirement of filing a New Drug Application with the FDA.   Many manufacturers could legally produce generic atropine products without filing New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), which made atropine ophthalmic solution a very cost-effective medication in the past. 

Since July 2014, Akorn, one of the many generic atropine ophthalmic solution manufacturers, filed an original NDA for atropine ophthalmic solution and obtained FDA approval. This act removed atropine ophthalmic solution from the FDA’s grandfather list. This requires any manufacturers, who wish to continue producing atropine ophthalmic solution to file for an ANDA and obtain FDA approval. This shift in FDA approval status on atropine ophthalmic solution has discouraged the rest of the generic manufacturers from continuing to produce the product and Akorn has become the only atropine ophthalmic solution manufacturer since January 2015. Due to this sudden drop in availability from multiple manufacturers, there has been a shortage of atropine ophthalmic solutions from Akorn, as well as a significant price hike on this medication.

Moving forward, we will expect to see only the Akorn atropine ophthalmic solution products in the market until more generic manufacturers have successfully obtained FDA approval on their ANDA. There is no estimated date on when this will happen.

Here is the current price and shortage status for the Atropine Sulfate 1% Ophthalmic Solution, Akorn

2ml Bottle, NDC 17478-0215-02 ---- AWP $30.74 (~ 1week supply if used 1 gtt QID)

5ml Bottle, NDC 17478-0215-05 ---- AWP $58.35 (~ 2 weeks supply if used 1 gtt QID) à shortage

15ml Bottle, NDC 17478-0215-15 ---- AWP $95.25 (~ 4 – 6 weeks supply) à back ordered

In a hospice setting, atropine ophthalmic solution was recommended in many hospice formularies and their comfort kits for the use of managing excessive secretions when used orally. Atropine injectable solution was sometimes used orally as well as a substitution when the ophthalmic solution was not available, but there is currently also a shortage of this formulation since February 2015.  Here are some comparable cost-effective alternatives for managing excessive secretions while atropine ophthalmic solution is in shortage (price quoted on 15 day-supply):

Hyoscyamine (Levsin) 0.125mg Sublingual tab (0.125mg QID) --- AWP $52

Glycopyrrolate (Robinul) 1mg tab (1mg TID) --- AWP $59

Atropine Eye Drop 5ml Bottle (1gtt QID) ---- AWP $58 à in shortage

With the current increase in price of atropine ophthalmic solution, the cost of managing excessive secretions routinely is roughly the same amongst atropine ophthalmic solution, hyoscyamine and glycopyrrolate (see above price comparison for 15 days).  However, atropine ophthalmic solution is a less cost-effective option for hospice comfort kits now due to its smallest non-breakable package size being a 2ml bottle (cost $30 per bottle) in comparison to Levsin or Robinul, which can be dispensed in smaller quantity such as 6 tablets ($5 - $8). It is highly recommended for hospices using atropine ophthalmic solution to evaluate the need to substitute atropine with hyoscyamine on their formulary, as well as their comfort kits due to the significant accessibility issues and cost-effective reasons. 



ASHP Drug Shortage Updates:


FDA Drug Shortage Database:




Medications for Managing Hiccups

Dr. Jim Joyner, PharmD, CGP

A hiccup is an involuntary reflex involving the respiratory muscles of the chest and diaphragm, mediated by the phrenic and vagus nerves and a central (brainstem) reflex center. A single episode can last for a few seconds to as long as several days. Persistent hiccups can last for months. There are a wide range of possible causes for hiccups including; stress or excitement, esophageal or gastric distension, liver disease, CNS lesions, or cancer. Irritation of the vagus nerve or the diaphragm is a common mechanism.  

Many drug and non-drug treatments have been used, but there is little evidence of any one superior approach to management; virtually all current data are anecdotal. When choosing a drug treatment strategy for hiccups, consider the suspected etiology, patient’s drug-allergy history, potential drug-disease state contraindications, and potential adverse effects from any proposed drug therapy.

Chlorpromazine (Thorazine) is the only drug with an FDA approved indication for treatment of hiccups. Haloperidol (Haldol) is a useful alternative. Chlorpromazine and Haloperidol should not be used in patients with Parkinson’s disease because they may exacerbate involuntary movements. Metoclopramide (Reglan) increases GI motility and may be especially useful if hiccups are related to esophageal or gastric distention. The muscle relaxant, Baclofen (Lioresal), is thought to have a direct relaxation effect upon the diaphragm and may be most useful in patients where an irritation of the diaphragm is suspected. Dexamethasone (Decadron) may be appropriate as an adjunct to one of the previously mentioned drugs if there is hepatomegaly or tumor involvement. All of these drugs are available as relatively low cost generics, so the choice of therapy should be based upon the suspected etiology behind the hiccups, the patient’s drug allergy history, and other health conditions that may predispose the patient to adverse drug effects. In difficult cases it may be necessary to combine two to three of the drugs listed below in order to achieve adequate results (haloperidol and chlorpromazine should not be combined because they exert a similar mechanism of action that would represent at therapeutic duplication).  

Common Doses for Hiccups: 

Chlorpromazine (Thorazine)  25-50mg Q6h po,pr

Haloperidol (Haldol) 1– 2mg Q6h po, sl

Metoclopramide (Reglan) 10-15mg Q6h po

Baclofen (Lioresal) 5 –10mg Q6h  po

Dexamethasone (Decadron) 2-6mg daily po


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