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The contents of this blog contain topics relevant to end of life care written by our own hospice clinical pharmacists. Continue to check this site regularly for the newest post or subscribe to the RSS feed below.
Drew Mihalyo, PharmD

What Do You Need to Know About State Opt-out Provisions, Access and Costs?

mortar 321795 1920A January 2017 article in the New York Times suggests concerns for pharmacists in the hospice care sector concerned with “aid in dying” impacts on practice and care

Last month, the New York Times ran an article, “Physician Aid in Dying Gains Acceptance in the U.S.” It outlines the current “Aid in Dying” debate among hospice and palliative care physicians and providers. Questions raised through this debate create ethical, legal, and professional issues for pharmacists and pharmaceutical companies.

The goal here is not to discuss the moral or ethical dilemmas each of us necessarily considers deeply and personally. For those who would like to do so, a 2011 article in “American Journal of Health System Pharmacy” may prove useful. Also, “Aid-In-Dying Practice in the United States Legal and Ethical Perspectives for Pharmacy,” was published in Research in Social and Administration Pharmacy (Summer 2016). The JAMA Journal from January 2016 focused on diverse issues clinicians face in death, dying, and end of life.

Additionally, clinicians may also wish to refer to position statements on the issues issued by American Academy of Hospice and Palliative Medicine (AAHPM) and Hospice and Palliative Nurses Association (HPNA).

Here, we’ll focus on implications of mainstream coverage in the January 2017 New York Times article. Specifically, this piece will address two issues with relevance to pharmaceuticals: state opt-out provisions, access and costs.

Issue 1: State Opt-Out Provisions
The New York Times article states that in the U.S. states that have opt out provisions for hospice physicians: “State opt-out provisions allow any individual or institution to decline to provide prescriptions.” It follows logically that pharmaceutical industry professionals would have a similar ability to decline to provide prescriptions.
Opt out provisions are determined at the state level. State laws impact pharmaceutical professionals, informing practices and procedures. State legislatures determine laws regarding professional pharmaceutical practice and govern access to particular types of medical procedures. Statutes differ from state to state, and may or may not resemble industry policy. We have a responsibility to remain current in our area of expertise.

Issue 2: Access and Costs
The article also delineates cost and access concerns of patients who would choose to end their pain and suffering by ending their lives. Less than one percent of hospice and palliative care patients in the four U.S. states with “Aid in Dying” provisions ever choose to exercise those rights. Those few hospice patients require access to a pharmacist willing to fill their prescriptions. Then, cost becomes a factor.

The New York Times notes the increase in cost for barbiturates from a couple of hundred dollars in years past, to $3-4,000 after insurance. The article reveals that Valeant Pharmaceuticals acquired Seconal, a commonly prescribed barbiturate, in advance of California’s 2015 legislation. Then, the company deliberately “spiked the price.”

Apart from ethics concerns, we are left with more questions than answers.
• Should pharmaceutical companies inflate costs for formerly affordable prescription drugs?
• How should price be determined?
• What mark-up can consumers realistically expect to pay for a prescription?

These types of questions have both broad and situational implications within pharmaceutical professions. We might also ask if intended usage of the drug should determine market price, or if substitutions are appropriate in terminal cases.

Without doubt, informed hospice pharmacists remain critical to pain and symptom management teams for those with serious illness or at end of life.


Drew Mihalyo is founder and president of Delta Care Rx.

About Delta Care Rx:
Delta Care Rx – http://www.deltacarerx.com/ – transforms and improves the hospice pharmacy industry through business transparency, innovation, extreme customer service, and the maintenance of vital community-pharmacy relationships. As a pharmacist owned, privately held provider, Delta Care Rx sets the industry benchmark for pharmacy benefit management, on-demand pharmacist services, and hospice tailored electronic prescribing.

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Holly Lassila, DrPH, MSEd, MPH, RPh

Acute Myocardial Infarction in Women

2016 12 28 10 12 46The American Heart Association recently released a scientific statement concerning Acute Myocardial Infarction in Women.1 Cardiovascular disease is still the leading cause of death in women in the United States and globally and of the 2.7 million women with a history of an (myocardial infarction) MI, more than 53,000 have died of an MI, and an estimated 262,000 were hospitalized for AMI and unstable angina. The differences in the clinical presentation between men and women have consequences for timely identification of symptoms, appropriate triage, diagnostic testing and treatment. Compared with men women are more likely to have pain in the upper back, arm, neck, and jaw as well as unusual fatigue, flu-like symptoms, dyspnea, indigestion, nausea/vomiting, palpitations, weakness, and a sense of dread and anxiety feeling.

Mehta LS, et al reported the top ten things to know about acute myocardial infarction in women:

1. Although there has been a reduction in cardiovascular mortality death in women in the US, there has not been a substantial decline in acute MI event rates or MI deaths in young women. 

2. Compared with older women, younger women are trending with worse risk factor profiles and higher mortality.

3. Plaque characteristics differ for women, and recent data have suggested a greater role of microvascular disease in the pathophysiology of coronary events among women even though epicardial coronary artery atherosclerotic disease remains the basic cause of acute MI in both men and women.

4. Date from autopsy studies have shown that women have an increased prevalence of plaque erosion compared to men, and that MI without obstruction coronary artery disease (CAD) is more common at younger ages and among women.

5. Any young woman who presents with an acute coronary syndrome without typical atherosclerotic risk factors should be suspected of having spontaneous coronary artery dissection (SCAD). This is a very rare condition and occurs more frequently in women. The clinical presentation of SCAD can be unstable angina, MI, ventricular arrhythmias, and sudden cardiac death.

6. Recent evidence suggests that depression in women is a powerful predictor of early-onset MI, showing a strong association with MI and cardiac death in young and middle-aged women than in men of similar ages. In the general population, depression is 2 times more prevalent in women than in men.

7. Women with risk factors such as high blood pressure and diabetes have an increased risk of heart attack compared to men.

8. As mentioned above, women are more likely to present with pain in the upper back, arm, neck, and jaw, as well as unusual fatigue, dyspnea, indigestion, nausea/ vomiting, palpitations, weakness, and a sense of dread, compared with men who present with central chest pain.

9. Research suggests that women are delayed in seeking treatment for acute MI compared to men. Reasons for the delay include living alone, interpreting symptoms as non urgent and temporary, consulting with a physician or family member and fear and embarrassment.

10. Women, compared to men, tend to be undertreated and are less likely to participate in cardiac rehabilitation after a heart attack.


 Submitted by: Holly Lassila, DrPH, MSEd, MPH, RPh; Hospice Clinical Pharmacist at Delta Care Rx


 References:
1. Mehta LS, et al; on behalf of the American Heart Association Cardiovascular Disease in Women and Special Populations Committee of the Council on Clinical Cardiology, Council on Epidemiology and Prevention, Council on Cardiovascular and Stroke Nursing, and Council on Quality of Care and Outcomes Research. Acute myocardial infarction in women: a scientific statement from the American Heart Association [published online ahead of print January 25, 2016]. Circulation. doi: 10.1161/CIR.0000000000000351.

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Sydney Janusey, PharmD

HAART and Palliative Care: A Combined Approach

2016 12 28 9 53 55

Drug therapies continue to evolve so often that the goals of their intended care for certain disease states also change. A classic example of this shift would be the medications used to treat HIV and AIDS. Less than a few decades ago the medications for HIV/AIDS were purely thought as palliative and were used to keep patients from suffering near the end of life. Now with highly active antiretroviral therapy (HAART) as a first line treatment option, patients are living without an imminent threat to their health status. However, there are a few points to consider when looking at HAART and patients at the end of their life in need of symptom management and palliation. The drugs used to treat HIV/AIDS come with a lot of side-effects and drug interactions, particularly interactions with medications used in palliative care. Palliative care in HIV/AIDS does not always have to be an alternative treatment, but one that can be combined with disease-state focused therapy1.

Important goals of palliative care include treating pain, fatigue, weight loss, nausea, vomiting, and depression. Here are some examples of medications appropriate for treating these signs.
1. For the symptom of fatigue, consider managing with prednisone, dexamethasone, or methylphenidate.2

2. For the symptom of weight loss, consider managing with prednisone, dexamethasone, or megestrol acetate (non-preferred).2
3. For the symptom of nausea and vomiting, consider managing with metoclopramide, haloperidol, prochlorperazine, promethazine, lorazepam, or corticosteroids.2
4. For the symptom of depression, consider managing with methylphenidate, prednisone, or dexamethasone.2

As medications are added to a patient’s care plan it is very important to consider a few crucial interactions between HAART and commonly used palliative care medications.2 The protease inhibitors ritonavir, indinavir, nelfinavir, saquinavir and amprenavir as well as non-nucleoside reverse transcriptase inhibitor (NNRTI) delavirdine interact with commonly used antidepressants including fluoxetine, paroxetine and sertraline. The NNRTIs efavirenz and nevirapine interact with anticonvulsants carbamazepine, phenytoin, and phenobarbital. In addition to these interactions on the basis of the cytochrome P450 enzyme the following medications should also be used with caution: meperidine, methadone, codeine, morphine, fentanyl, dronabinol, benzodiazepines and zolpidem.2

Inevitably there will come a time when discontinuation of HAART is warranted.2 With this discussion comes the question of benefit versus. risk of therapy.2 The benefit is based on the patient’s prognosis and treatment goals for their end of life care. The benefits of continuing therapy include protection against encephalopathy or dementia, relief of constitutional symptoms and a psychological benefit from comfort that treatment is being maintained.2 The risk includes the continued build up of adverse effects from medications no longer truly working, patient comfort, and complication of end of life care and advance planning.2

As palliative care services continue to grow and play a greater role the trend is shifting towards palliation of symptoms.2 These medications should be given much earlier in care allowing patients to be comfortable for a longer period of time than just at the end of life.2 Eventually, however, removing HAART with a heavy side-effect profile and focusing on symptom palliation will lead to the most comfort for the patient and ideal treatment for their last days.1


 Submitted by: Sydney Janusey, PharmD; Hospice Clinical Pharmacist at Delta Care Rx


References:
1. O’Neill, Joseph F et al. A Clinical Guide to Supportive and Palliative Care for HIV/AIDS. US Department of Health and Human Services. Health Resources and Services Administration. HIV/AIDS Bureau. 2003. Accessed February 28, 2016.

2. Selwyn, Peter A; Forstein, Marshall. Overcoming the False Dichotomy of Curative vs Palliative Care for Late-Stage HIV/AIDS. JAMA, Vol 290, No 6. August 13, 2003.Accessed February 16, 2016.

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Michelle Mikus, PharmD

Purple is NOT the New Yellow: A Clinical Look at Purple Urine Bags

From orange to red and all shades of yellow, most clinicians can list reasons for discolored urine. When urine appears purple, however, both patients and clinicians are taken off guard. Interestingly enough, Purple Urine Bag Syndrome (PUBS) is a very real however rare clinical phenomenon that cannot go unnoticed.

Purple urine bags are just that -the bags themselves appear to have a purple tint. The urine itself is not discolored. This happens when gram-negative bacteria that produce two specific enzymes (phosphatase and sulfatase) are present in the urine and react with PVC urinary catheters and bags. While urinary tract infections are common, especially among patients in long term care facilities, PUBS is not common since it is dependent on bacteria producing those specific enzymes.

Patients that present with PUBS are often geriatric females with a history of constipation and are catheterized. Patients most often have multiple comorbid conditions, however this could be coincidental due to the age and environment of care of the patient population from many case studies. Alkaline urine plays an important role as does dehydration. Constipation allows for an overgrowth of bacteria which introduces more potential pathogens to the body (including E. Coli). The final component of the purple color is the presence of tryptophan in the body, which when in the presence of sulfatase and phosphatase in an alkaline environment is converted to indigo (blue) and indirubin (red). When indigo and indirubin combine, they appear purple to the eye.

A purple urine bag is very apparent indication of a urinary tract infection that needs treated. If not treated quickly, septicemia can occur and outcomes can be fatal, especially considering the population this most often occurs in. By treating the underlying infection and therefore eliminating the presence of phosphatase and sulfatase in the urine, the urine bag for a catheterized patient will no longer turn purple in color when replaced.


 Submitted by: Michelle Mikus, PharmD; Hospice Clinical Pharmacist at Delta Care Rx; Pharmacy Manager at ProCure Pharmaceutical Services


 References:

  1. Lin CH. Huang HT. Chien CC, et al. Purple urine bag syndrome in nursing homes: ten elderly case reports and a literature review. Clin Interv Aging. 3:729-34. 2008

  2. Harun NS, Nainar SK, Chong VH. Purple urine bag syndrome: a rare and interesting phenomenon. South Med J. 100:1048-50. 2007

 

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Delta Campus Pharmacy Student

Lack of E-Prescribing Controlled Substances by Doctors

2016 08 22 14 07 33A recent article in USA Today discussed the fact that although electronic prescribing of prescriptions, specifically controlled substances, would be a great way to cut down on abuse and fraud the majority of the United States is not utilizing this system. Only 7% of doctors are electronically prescribing controlled substances today. Currently only three states actually require that controlled substances be e-prescribed, however, only two of these three actually enforce this law. The three states that require controlled substances to be e-prescribed include Minnesota, New York and Maine.

Minnesota was the first state to require e-prescribing of controlled substances, although they do not allow physicians to be penalized for not doing so. New York requires physicians to check the online database to see if patients are getting controlled substances elsewhere before prescribing. They are then required to e-prescribe these prescriptions or they could face legal action. Maine became the third state to require e-prescribing of controlled substances in April 2016 and starting January 2017 physicians could face fines and/or jail time for not doing so.

Opioid abuse is one of the leading causes of death in the country currently, much of the abuse stemming from prescription painkillers. Physicians e-prescribe non-controlled medications on a regular basis and now that they have the ability to electronically send prescriptions to pharmacies for controlled substances they should be utilizing this software. Eliminating paper prescriptions can ensure that the patient is not altering the prescription in anyway, it would lessen the chance of patients ‘doctor-shopping’ to get multiple prescriptions, and it could prevent the chance of physician prescription pads being stolen which we see in the news all too often. Some people are afraid that although e-prescribing may make it harder for drug users to get their hands on controlled substances it could lead to these individuals turning to heroin to get their fix instead. Either way you look at the issue it is amazing that so few physicians are taking advantage of this new technology simply as an easier way to keep records if nothing else.

Hospices utilizing e-prescribe technology automatically meet federal and state regulations regarding how prescriptions are issued for controlled substances. Delta Care Rx is the only hospice pharmacy benefit manager in the United States that has developed their own proprietary e-prescribing platform for hospice clients. Currently, more than 250 clinicians use the Delta Care Rx e-prescribing tool. The number of hospice clinicians utilizing the Delta Care Rx e-prescribing technology is expected to quadruple by 2017 says Drew Mihalyo, PharmD who is the President and COO of Delta Care Rx.


Submitted by: Stephanie Stuparitz, PharmD Candidate 2017, Duquesne University


Reference:
O’Donnell J. Most doctors don’t use e-prescribing for opioids. USA Today. May 19, 2016: 3A.

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