Naloxone: Pharmacists aid in the fight

Almost 70% of all drug and poison related deaths were attributable to opioids from 2007 to 2013, according to the Virginia Department of Health Professions. Heroin related deaths have been on the rise: in the first half of 2015 alone, there were over 100 overdose-related deaths in the state of Virginia. In the face of involvement by law enforcement and various agencies, pharmacists have been deemed into a position to help curb these fatalities.

The REVIVE! program for Opioid Overdose and Naloxone Education was created in 2013 for the State of Virginia, led by the Virginia Department of Behavioral Health and Developmental Services (DBHDS). The REVIVE! program provides educational materials to professionals and other stakeholders on how to recognize and respond to an opioid overdose situation by administering the opioid antidote Narcan(naloxone). Since June of 2015, REVIVE! has been expanding from a pilot project to a statewide program, thanks to the patronage of Del. John O’Bannon (R-73). Virginia HB-1458 was passed, which authorized pharmacists to dispense naloxone pursuant to an oral, written, or standing order in accordance with protocol approved by the Board of Pharmacy. With this program, pharmacies may wholesale distribute naloxone via invoice to law enforcement or fire fighters who have completed training programs as required by law.

In speaking to a few practicing pharmacists, I became aware that some practitioners did not know these educational programs and laws had been created. These types of programs, where they exist, differ due to the varying prominence of opiate overdose and the fact that these bills are only passed at the state level. This makes HB-1458 and the REVIVE! program only relevant through the Commonwealth of Virginia.

To get more insight into the topic, I held a brief interview with Caroline Juran, Executive Director of the Virginia Board of Pharmacy. She has been providing assistance to the legislators during the General Assembly session and the Board of Pharmacy as it adopted a protocol for pharmacists to dispense naloxone pursuant to a standing order. Her work centered on trying to increase awareness of the new law when speaking at pharmacy professional association meetings. Fortunately, she had not seen much resistance to the newly passed laws, but she still believes,” that there is a need for increased education and awareness of the law, including the civil liability protections, and how to implement a standing order for dispensing naloxone.” It is imperative that we raise awareness of educational programs and laws formed around opioid overdoses.

At this point, the pharmacists that are dispensing Naloxone pursuant to a standing order are not mandated to report to the board, so no statistics related to the prevention overdose-related fatalities can be identified yet. In a memorandum by President Obama in October 2015, he stated improving access to treatment was specifically noted as one of the largest actions in the Nation Drug Control strategy. The press release unveiled plans for naloxone use and training programs for pharmacies like CVS Health and Rite Aid. Also noted were increased efforts by the American Pharmacists Association, the National Community Pharmacists Association, American Society of Health System-Pharmacists and The National Association of Boards of Pharmacy.

"Pharmacists can play an integral role in protecting patients from opioid overdose," stated Caroline Juran. What does this entail? It includes identifying high-risk patients, encouraging responsible naloxone use by both patients and care givers, and providing training on the proper administration of the drug. 

This is what our role is shifting towards due to this epidemic: comment below on your thoughts. Is this intervention truly our responsibility? Does this level of intervention and assistance require more training than basic CE's can provide? How can pharmacy technicians help us reach these patients?

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Stepping Up Patient Assessment: Part III

This is the final post in a series of three meant to highlight the increasing importance of patient assessment for pharmacists.  Each post was written to illuminate how pharmacists can help address a number of public health issues.  Specifically, Part I was devoted to pharmacists taking on a greater role to help with medication adherence.  Part II emphasized the contributions pharmacists make in reducing falls risk among patients; and now Part III, the last installment in the series, will serve as a call to action for pharmacists to help address the growing problem of substance abuse.

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You’d have to be living under a rock not to know that substance abuse is a major public health crisis in the United States.  After all, it has even spilled over into the 2016 presidential election campaigns.

According to the National Institute on Drug Abuse, alcohol and tobacco remain the most common and costly substances of abuse for our healthcare system.  However, what has elevated substance abuse to an epidemic level is the increasing use of opioids, such as heroin and prescription pain relievers.  

This year in the January 1 Morbidity and Mortality Weekly Report (MMWR), the CDC revealed a 15-year, 200% increase in the rate of overdose deaths due to opioids; and specifically during 2014, with the exception of children < 15 years of age, every age group, including the elderly (> 65 years) showed a rise in opioid-related deaths.  In addition this MMWR indicated a 3-fold rise in heroin overdoses since 2011.  

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Over the past decade training and continuing education for pharmacists regarding substance abuse has primarily focused on building awareness and calling on pharmacists to report abuse to the prescriber and law enforcement, as well as utilize their state’s prescription drug monitoring program (PDMP) to help reduce abuse and diversion.  More recently, pharmacists have procured greater access and ability to help patients obtain naloxone.  (More to come on Naloxone in a future post.)

In the spirit of pharmacists seeking our rightful recognition as healthcare providers, I believe there is an even greater role that pharmacists can serve in helping address and reduce the risk of substance use disorders.  You guessed it! It has to do with stepping up our role through assessment and intervention. 

I was recently awarded a grant from the Substance Abuse and Mental Health Services Administration (SAMHSA) for my institution, Shenandoah University.   We are using an interprofessional approach to deliver Screening, Brief Intervention & Referral for Treatment (SBIRT) training to health professionals and graduate health professions students.  We are one of only a few grantees emphasizing the importance of training pharmacists in SBIRT.  

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You might be thinking, “why would pharmacists want this training”?  Our accessibility to the public and our ability to establish rapport with patients is key.  Addiction is a disease, but it stems from poor choices and behaviors.  Pharmacists have been successful in using motivational interviewing to help with behavioral change such as with smoking cessation.  In the end, particularly since the greatest predictor for heroin use is a previous misuse of prescription opioids,  if we are not assessing for the risk of substance use disorders, then we are part of the problem.   For these reasons, pharmacists are strongly positioned to make a difference. 

In northwestern Virginia, where Shenandoah University is located, and where deaths from

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heroin and other opioids have steadily climbed, the hope is that pharmacists, trained in SBIRT, and on the front-line of healthcare will be able to help identify patients at risk and provide life-saving, timely intervention. 

I welcome your comments.  Is monitoring the PDMP enough? Are you SBIRT trained?  Tell me what you think of the pharmacist’s role in SBIRT for substance abuse prevention and intervention.  Can we make a difference?

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Daraprim: Impact of Drug Price Hike

Pyrimethamine is recommended in combination with other therapies as first-line treatment for toxoplasmosis in HIV-infected patients.  The CDC has labeled toxoplasmosis as a "neglected" parasitic infection and elevated its priority as a public health issue. If left untreated, toxoplasmosis in patients with weakened immune systems can have very severe consequences, including seizures, life-threatening illnesses such as encephalitis, and even death.  However, as of June 2015, pyrimethamine, a potentially life-saving therapy, is no longer available in community pharmacies in the United States; it is only available through a special pharmacy program.

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The effect of the overnight price hike of the toxoplasmosis drug pyrimethamine (Daraprim), recently acquired by Turing Pharmaceuticals, resonates even beyond its mere 2,000 users.  In recent years, the cost of other generics such as doxycycline and cycloserine have climbed so steeply that some patients revert to not filling these prescriptions.  While there are alternatives for these products to treat their respective illnesses, there is currently no effective alternative for toxoplasmosis apart from pyrimethamine.

Given the price hike from $13.50 to $750 per pill, and the drug’s availability only through a special pharmacy program in the United States, access to pyrimethamine is limited. In addition, patients with HIV and other infectious diseases, as well as pregnant women, are especially at risk for toxoplasmosis.  Patients can become infected if they come in contact with cat feces that contain the Toxoplasma gondii parasite, eating or drinking contaminated food or water, using utensils or kitchen tools that have come in contact with raw meat harboring the parasite, eating unwashed fruits and vegetables, or receiving an infected organ transplant or transfused blood. According to the IDSA, the cost of combination treatment for toxoplasmosis, including pyrimethamine, is at least $336,000 per year.  Although Turing Pharmaceuticals says they will use the increased profits from pyrimethamine to research better treatments, for now, patients who need this drug are medically and financially at risk due to the extreme price hike.  

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Generic drugs were initially expedited for market in 1984 as a means of providing cost savings to consumers; however, the price hikes over the past few years have made access to these supposedly cheaper therapies more difficult for some patients.  Earlier this year, legislation was introduced into Congress proposing that drug manufacturers pay a rebate to Medicaid when the price increase for generics exceeds inflation. Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) introduced the Medicaid Generic Drug Price Fairness Act in the Senate and the House, respectively.  In addition, the Office of the Inspector General of the Division of Health and Human Services is currently investigating generic price increases.  

Despite the effort put forth to increase awareness of this issue in the legislature, experts are still divided on how to rein in rising costs.  The CEO of Generic Pharmaceutical Association, Ralph G. Neas, denies the rising costs of generics as a problem, stating that "the price of brand drugs has almost doubled, but the price of generic drugs has been cut roughly in half”, based on the Express Scripts 2013 Drug Trend Report.  Neas believes that encouraging more timely reviews of generic drug applications at the FDA will provide consumers with more options, and will help lower the price of currently marketed generic drugs.

So what can we do about these price hikes? Are these price hikes, like the one recently seen with pyrimethamine, artifacts of corporate greed? How can pharmacists advocate on behalf of patients in hopes of preventing similar action by other companies? How much is too much when a life is on the line?

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Stepping Up Patient Assessment: Part II

There are so many facets to consider when thinking about what constitutes good health.  As much as the perceptions of good health can vary among our patients,  it is also important to remember that patients do not always readily volunteer information.  In other words, if we do not check for, ask about or assess, then the problem will remain unbeknownest and unaddressed.

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My last post focused on the topic of pharmacists taking on greater roles in the area of patient assessment.  That earlier post called on pharmacists to accept accountability and to proactively take on the role of assessing and addressing the highly prevalent and tremendously costly problems associated with medication non-adherence.   I promised then that I would return to this topic of the advanced role of the pharmacist in "patient assessment", and how ideally pharmacists are positioned within our healthcare system to help reduce risk, injury and overall healthcare costs.  Specifically, I mentioned I would use this post (and a future one) to prompt pharmacists and student-pharmacists in using their knowledge and skills to address two increasingly important, yet previously under-addressed and costly public health problems:  falls among seniors and substance use disorders in general.

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This past Wednesday marked the beginning of fall and all the brilliant colors and crisp weather that Mother Nature will soon usher our way.  The Center for Disease Control and Prevention (CDC) and the National Council on Aging (NCOA) remind us annually that the first day of fall coincides with National Falls Prevention Day.  Lately, falls and falls risk have been a big part of my personal and professional life. During this past year, I have had the wonderful opportunity of chairing a committee for the American Society of Consultant Pharmacists (ASCP) on falls risk assessment and risk reduction. We have been working on materials specifically designed to help pharmacists in various practice settings assess their patients for falls risk.  Ironically, while conducting part of this work, my mother, who lives in another state, incurred a fall resulting in injury and a hospitalization.  Despite the serious nature of my mother's fall, I watched with an elevated sense of awareness and curiosity, as every single healthcare team member provided wonderful care for her injuries; yet, not one healthcare professional assessed the multi-factorial nature of her fall.

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Given the "baby boomer" statistics, every day our senior population is growing.  As the senior population grows, so does the incidence of falls.  According to the NCOA, each year, one out of every three seniors falls.  More importantly, seniors who have fallen, without injury, often do not report the fall.  Early intervention is important because the history of a fall is a major risk factor for subsequent falls.  Falls frequently lead to injury, loss of independence and death.  In fact, falls are the leading cause of both fatal and non-fatal injury among individuals age 65 or older.  The CDC has created the STEADI toolkit and training materials to help healthcare providers screen and reduce falls risk among their patients.  STEADI stands for "Stopping Elderly Accidents, Deaths and Injuries".  The CDC has estimated that the integration of STEADI in practice by 5000 healthcare providers, over a five-year period, can help prevent a million falls, and save $3.5 billion in falls-related medical costs.

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The majority of seniors reside in the community and the community pharmacist is one of the most trusted and most accessible healthcare providers.  Furthermore, given that medications are a frequent cause of falling, pharmacists who learn how to integrate a falls risk reduction program into their practice have the potential to make a huge difference in this public health initiative and the lives of their patients.

Please comment regarding your thoughts on pharmacists assessing for falls risk.  Share your opinions on how best to integrate a falls assessment service into your practice.  Finally, if you are interested in piloting a falls risk assessment service as a part of your practice, let me know.

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Stepping Up Patient Assessment: Part I

  

The past month has kept me busy with administrative duties, teaching and writing a grant proposal.  After taking a bit of time to decompress from the intense hustle and bustle of meeting the grant submission deadline, I started to reflect on a common theme that appeared to be threaded across most of my work of late, including the grant proposal.  That thematic tendril was tied to the act of teaching or rather training students in patient assessment.

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It dawned on me that in pharmacy we do a pretty darn good job of teaching students patient assessment in the context of medications.   I mean "duh", isn't pharmaceutical care or medication therapy management what we're supposed to teach student pharmacists?  Isn't that our role as pharmacists? Certainly, but I also believe pharmacists are ideally position within healthcare to provide a whole host of patient assessment services and interventions, which reduce risk for injury.

So to help drive this premise home, this post and the next one will cover three of what are many potential assessment services that pharmacists could and should actively embrace:  medication adherence, substance use disorders, and falls risk assessments.   The first one, medication adherence, is already within our acknowledged wheelhouse of expertise.

Reams of information have been published over the past few decades on the occurrence, associated risk factors, predictors and costs, as well as strategies to improve medication non-adherence.   So why is it that despite how much better informed we are about the issue, medication non-adherence remains so prevalent, so problematic and so costly?  There are many factors, but I believe there are two key reasons.  First, non-adherence is a behavior coupled to both internal beliefs and external demands; and as we all know, human behavior is complex and very difficult to change.  Second and perhaps most importantly, no profession in healthcare has truly stepped up to own the issue of medication non-adherence.  Perhaps this is due to the complexity of the problem, but certainly pharmacists are well equipped to take on this multi-billion dollar problem.


I recently lectured on the topic of medication non-adherence in our Geriatrics Assessment elective course, open to second and third year student pharmacists.  As typical for my lecture, I covered the common non-adherence statistics, introduced the students to the World Health Organization's Five Dimensions of Adherence, demonstrated a number of adherence assessment tools and shared a variety of adherence aids and devices.   However, on this day, I also used an active learning strategy in class to engage small groups of students, using digital audio recordings, to critically think about the issues surrounding medication non-adherence and the pharmacist's role.   I did this through a series of quick responses to "impromptu" questions and a hand-held recording device, which was passed from one student to the next.  The following podcast link shares one group's quick response to the question "what can pharmacy/pharmacists do to step up to better own or take on the problem of medication non-adherence"?

Listen Here

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Now when you listen to these students' replies, I know experienced pharmacists will, through a skeptical ear, dismiss their responses as impractical musings of the naive and inexperienced.  However, if this is your first impression, I ask that you listen again, and listen not within the context of how pharmacy has been practiced, but with the ear and vision of what our practice should be.  Then ask, if we took up this challenge of owning the issue of non-adherence, and we followed the advice of these students, would we be closer to a solution?   I think so!  What do you think?  When was the last time you or a pharmacist you work with did a comprehensive medication non-adherence assessment?  Are we doing enough as pharmacists to change non-adherent behavior?  What are your thoughts on how we can step up as a profession?

Part II will address the pharmacist's role in stepping up assessment for substance use disorders and falls risk.  Until then, I look forward to your comments on adherence.

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