Within the last decade there has been a countless number of synthetic psychoactive drugs emerging throughout the United States and International drug markets. Several of these compounds are derivatives of common illicit drugs currently regulated under the Controlled Substance Act, such as fentanyl, MDMA (commonly referred to as ecstasy), and cannabis. Titling, labeling, and storing these products for nonhuman research purposes and marketing these analogs in such a manner currently circumvents legislations and law enforcement, allowing these products to enter the market1.

In 2013, a pattern of 10 overdose deaths of suspected drug users occurred in Rhode Island with similar toxicology reports. Further investigation using enzyme-linked immunosorbent assay (ELISA) was performed and indicated that all 10 patients tested positive for fentanyl. Paradoxically, it was noticed that gas chromatography/mass spectrometry (GM/MS) did not detect fentanyl but instead was positive for a synthetic derivative of fentanyl, acetyl-fentanyl2. Acetyl-fentanyl appears to be more potent then oxycodone and up to five times more potent than heroin. It may also present more challenges for clinicians when treating patients suspected of heroin overdose who may present with characteristic symptoms such as lethargy, disorientation, shallow breathing, bradycardia, hypotension, and if conscious may claim they use heroin or oxycodone. Unbeknownst to them, they may have been exposed to acetyl fentanyl instead. Fortunately, the clinical course of action for opioid overdose does not depend on the exact compound; thus naloxone is still the standard therapy of treatment but may require higher doses for acetyl fentanyl intoxication. Clinicians administering naloxone, however, should use caution, by avoiding the use of large doses until the patient fails to respond to standard doses of treatment1.

PMMA (para-methoxy methamphetamine) is another structural analog recently encountered in illicit markets and is structurally more similar to MDMA than to amphetamine or any other known stimulants, yet the onset of action is longer in comparison to MDMA, which may lead to frequent dosing. This becomes even more problematic due to the fact that PMMA has a narrow margin of safety, exhibiting only a two to four fold difference between the

dose needed in order to experience the psychological effects and the lethal dose3. PMMA and the first reported associated deaths occurred in Spain in 1993. This was followed by deaths spanning countries such as Denmark, Germany, Taiwan, Israel, Norway, and Canada from 2003 to 2012.

Many patients may be unaware that they may be exposed to PMMA when taking the associated illicit drug MDMA due to the fact that there is known to be extensive variability amongst marketed MDMA products, which may contain multiple sympathomimetic drugs (e.g., dextroamphetamine, methamphetamine, cocaine, etc.). The precise drug content being unknown to both the user and clinician may further complicate matters as there is an increase in the release of associated neurotransmitters such as dopamine, serotonin, norepinephrine and other neurotransmitters seen with these products. Thus, it becomes increasingly advantageous for clinicians to become familiar with PMMA toxicity, which is characterized by: progressive multiorgan dysfunction leading to serotonin syndrome, shock, and cardiovascular collapse, followed by death. The median time between exposure and hospital presentation is around 6 hours, and the time between exposure and death is roughly 17 hours4.

Summer 2015 ◊ Issue Eight

Written by: Tyler Spink

The Dangers Associated with

Synthetic Analogs of Illicit Drugs

PharmMom………………..……………...…..…….Page 3

Student’s Study Abroad……………………......Page 4

What Facebook “Likes” and Comments Can Teach

Providers……………………………………….........Page 8

Picky About Pharmacists…………………..…..Page 10

I seek Belviq, and stat Vimpat………………..Page 11

Also In This Issue

Acetyl-fentanyl (left) vs. fentanyl (right). Though significantly more potent than heroin, both have been used as adulterants in Northeastern heroin batches.

PMMA toxicity is also accompanied by various clinical symptoms and vital signs, which may aid the clinician in early diagnosis. These clinical symptoms include: multisystem dysfunction including hepatic injury, acute kidney injury, rhabdomyolysis, coagulopathy, cardiac ischemia, sodium-channel blockage, neuromuscular abnormalities, altered mental status, and hyperthermia associated with serotonin syndrome. Patients may also present with a HR 160 beats/min, BP 89/43 mmHg, Respiratory rate 40 breaths/min, Oxygen saturation 81% and temperature 39.4˚C⁴. Clinician familiarity with these common signs and symptoms associated with PMMA toxicity may aid in the early diagnosis and prevention of PMMA related overdoses.

An additional set of synthetic compounds which have become increasingly popular within the last decade are synthetic cannabinoids (SC). Although first developed as a research tool intended to explore the endocannabinoid system for potential therapeutics, SC’s increase in popularity can be attributed to their exploited advantages such as intense psychoactive effects, lack of detectability in routine urine drug tests, and the fact that until recently, many were considered of legal status under most jurisdictions. For instance, a survey conducted at the University of Florida in September of 2010 found that 8.1% of respondents reported a lifetime SC use, where 68% of respondents were male users and 32% were female users⁵. Many synthetic cannabinoids are now Schedule I drugs under the US Controlled Substance Act. As new synthetic cannabinoids are scheduled, more structurally diverse cannabimimetic compounds emerge, which may not be covered under current regulations. To date, hundreds of SC’s exist and are categorized into thirteen different structural groups, many of which are 2-100 times more potent than the psychoactive compound in cannabis, THC.

SCs appear to have either full or partial agonist intrinsic properties similar to THC depending on the particular compound. They elicit their cannabimimetic effects by

interacting with CB1 and CB2 cannabinoid receptors. CB1 activation has been shown to be associated with down regulation and decreased intracellular levels of cAMP which produces a cascade reaction of cellular signaling and inhibition of neurotransmitters such as acetylcholine, dopamine, noradrenaline, glutamine and γ-aminobutyric acid (GABA)6. Although SCs seem to be significantly less lethal compared to the previously mentioned synthetic analogs of fentanyl and MDMA, with deaths being quite rare, there have been over 200 reported documentations of acute intoxication cases resulting from SC, with symptoms including agitation, irritability, restlessness, anxiety, confusion, short-term memory loss, cognitive impairment and psychosis. Physical signs include: dilated pupils, reddened conjunctivae, nausea and vomiting, slurred speech, shortness of breath, hypertension, tachycardia, chest pain, muscle twitching and sweating.

Exploitation of the advantageous psychoactive effects of synthetic compounds is increasing on a global scale, further promoting the popularity and use of synthetic compounds and illicit drugs. As scientific advancements continue to expose the serious consequences of using these compounds, the need for well-informed clinicians becomes vital, as seen by a survey report stating that many clinicians feel overwhelmed, underprepared, and uncertain when dealing with novel psychoactive drug intoxication and overdoses7. Thus, increasing awareness becomes crucial in order to provide clinicians with sufficient information needed for guidelines and identification of symptoms when presented clinically.

References:

¹Strogner, John M. "The Potential Threat of Acetyl Fentanyl: Legal Issues, Contaminated Heroin, and Acetyl Fentanyl “Disguised” as Other Opioids." Annals of Emergency Medicine 64.6 (2014): 637-39. PubMed. Web.

²"Notes from the Field: Acetyl Fentanyl Overdose Fatalities — Rhode Island, March–May 2013." Centers for Disease Control and Prevention (2013): Web.

³Steele TD, Katz JL, Ricaurte GA. Evaluation of the neurotoxicity of N-methyl- 1-(4-methoxyphenyl)-2-aminopropane (para-methoxymethamphetamine, PMMA). Brain Res 1992;589:349-52.

⁴Nicol, Jennifer J.E., Mark C. Yarema, Graham R. Jones, Walter Martz, Roy A. Purssell, Judy C. MacDonald, Ian Wishart, Monica Durigon, Despina Tzemis, and Jane A. Buxton. "Deaths from Exposure to Paramethoxymethamphetamine in Alberta and British Columbia, Canada: A Case Series." Canadian Medical Association Journal Open (2015): E83-90. PubMed. Web. 19 May 2015.

5Castaneto, Marisol S., David A. Gorelick, Nathalie A. Desrosiers, Rebecca L. Hartman, Sandrine Pirard, and Marilyn A. Huestis. "Synthetic Cannabinoids: Epidemiology, Pharmacodynamics and Clinical Implications." Drug and Alcohol Dependence 144 (2014): 12-41. PubMed. Web.

6Mechoulam, Raphael, and Linda A. Parker. "The Endocannabinoid System and the Brain." Annual Review of Psychology 64 (2013): 21-47. PubMed. Web.

7P.M. Lank, E. Pines, M.B. Mycyk. “Emergency physicians’ knowledge of cannabinoid designer drugs.” Western Journal of Emergency Medicine: Integrating Emergency Care with Population Health 14 (2013), pp.467-470 Web.

“Many synthetic cannabinoids are now

Schedule I drugs under the US

Controlled Substance Act.”

MDMA (ecstasy, left) vs. PMMA (right). MDMA is illegal, but PMMA appears to be far more dangerous.

Be ing a parent has been the most rewarding privilege ever bestowed upon me. So when I made the decision to pursue a PharmD, I was

concerned that the demands of pharmacy school might compromise my ability to raise a child and make time for my family. Soon after starting my first semester, I realized that (1) pharmacy school is as tough as I was told it would be and (2) careful time management is the only strategy for success, particularly in my case. I have certainly had to sharpen my time management capabilities in order to survive my first year of pharmacy school while being a mom. I’ve relied heavily on the support of my family, as they were my childcare team when I needed to be in class or in need of a few hours to watch lectures and prepare for exams. Having my husband and two mothers around to assist me has been an absolute blessing and I cannot imagine how I would have been able to do it alone.

Many people have asked me what it is like to be in pharmacy school while raising a one year old, and for the most part I respond with a smile to show that I am still surviving. The truth is that every day has its challenges and there is no such thing as a typical day for me. There are days that I am faced with having to choose to go to class when my son is not feeling well, enduring sleepless nights to catch up on lectures and assignments, or days when I am feeling heartbroken after going the entire day without spending time with my son. These are just a few of the trials that I face. Some people would say that becoming a parent is one of the biggest adjustments of life and it’s true, but I found myself adjusting for a second time when becoming a pharmacy student in order to juggle school and family life. My sleeping and studying pattern had to adjust, priorities had to change, and I learned that parenting is not so much about the amount of time you get to spend with your children, but how you spend that time. My time

has become more valuable than anything and though I only get three hours of sleep every night, I am content because I am certain that my time is spent wisely. I just hope that after three more years of pharmacy school, I am able to readapt and go back to getting a solid 6 to 7 hours of sleep again. I have been told that the second year of pharmacy school is the most difficult, so as my 2PD year begins I am feeling nervous yet very hopeful. I will soon be faced with even newer challenges, particularly relating to childcare since the family support that I once had will be limited to some extent. In response, my husband and I recently enrolled my son in full time childcare--which will also be a new adjustment for me in the upcoming school year.

Looking around, I am certainly not the first or only person to take on this journey of parenthood while furthering my education, and I will not be the last. A study carried out by the Institute for Women’s Policy Research in 2014 showed that 4.8 million college students in the U.S. are raising children. Within the College of Pharmacy, there are fellow classmates who are also parents whom I relate with and share common experiences. I have been so amazed by the amount of support and encouragement that I have received from my classmates and faculty. I used to believe that raising my son while in pharmacy school would be a stumbling block, but I was totally mistaken and have come to realize that it is absolutely achievable. By staying focused, managing my time wisely and seeking the support of family and friends, I was able to successfully complete my first year of pharmacy school while simultaneously raising my son.

These are some of the tips I have received and sort of learned along the way are:

My experience is different from the next person’s, and certainly there are different ways to achieve success as a pharmacy student while raising children. Whatever the case, I hope to encourage anyone who is a parent and considering pharmacy school to go for it. I started pharmacy school when my son was just 9 months old and throughout his development, I have not missed a single moment or milestone in his life. Being in pharmacy school has not compromised the ability to raise my son, but instead it has enhanced and redefined the parenthood experience for me.

1. Be sure to dedicate a certain amount of time for studying and a certain amount of time for family. 2. Family time is strictly that and so when I arrive home, all school work seizes. 3. Study when my son goes to sleep and make every effort to be the one to put him to bed before resuming

my studies. 4. Never hesitate to ask for help when I need it either with school or with my son. 5. Rely on my faith in God as a source of strength and inspiration because all of it can be quite draining

and overwhelming at times.

Balancing pharmacy

school and parenthood

Written By: Judith John

This past May 2015, students from around UF’s College of Pharmacy campuses set off to the countries of Malta and Italy to learn about the world of pharmacy overseas with the guidance of Professors Carol Motycka and Douglas Covey. We visited universities, community pharmacies, hospitals, and historic pharmacies in the hope that we could capture the essence of the past, present, and future of pharmacy in that area of Europe. Every university visited gave us the opportunity to listen to presentations on their pharmacy program and history, in addition to allowing us to give presentations on our programs and on the pharmacy profession in the United States. During our days abroad, we were also given time for cultural experiences in each city so that we could learn not only about the countries but the people as well.

Beginning in Malta, we spent two days at the University of Malta speaking to pharmacy students, international students, and PhD students who all have their own accord of the career and have done work on different research topics in the field of pharmacy. We also visited Karin Grech Hospital, where we were given the opportunity to review a patient case when entering the hospital, deduce what should be added to her drug regimen, and even speak to the patient about her current condition. This was one of the most rewarding experiences and a good learning opportunity during our time in Malta.

After a few days in Malta we made our way to the heart of Italy, Rome, where we began our excursion through the country. We visited a historical pharmacy, Farmacia S. Maria della Scala, where we were guided

through the history of the 17th century pharmacy. With a few cultural experience days we enjoyed exploring the city and its many historical sites from the Colosseum and Palatine Hill to Vatican City. During the days that followed, we visited the University of Rome and their pharmacy program along with AIFA, Agenxia Italiana

del Farmaco, which is similar to the Food and Drug Administration in the United States. Learning about the differences between pharmacy school, the career, and the administration side of pharmaceuticals put in perspective how we should appreciate the work put into making the career and maintaining it. Both countries have unique differences in their systems that should be admired.

Continuing our adventure abroad, we traveled to the city of Siena in the Tuscan area. Here we actively engaged

Written By: Jaclyn Kilsgaard

“It was great to meet and

interact with pharmacy

students from around Italy and

Malta. We were able to

compare our different

programs one-on-one.”

- Kristina Nicol

Orlando Campus

with pharmacy students at the University of Siena after presentations, during lunch, and during an evening out. It was interesting to hear about their perspectives and ideals concerning where they want to spend their future in pharmacy and opinions on America. While in the Tuscan area we took an entire day to take a tour

of Tuscany including visiting an organic winery, Il Cocco, to learn the art of tasting wine and the process. This was a very beneficial part of our trip since we had drivers that explained a lot about the area, and we were able to see most of the countryside throughout the day with a few stops in between.

During the next portion of our adventure, we were able to have a few cultural experience days in Pisa as well as in Cinque Terre, where we stayed for the weekend. During the weekend we had the opportunity to stay in

Riomaggiore and explore any of the other four cities by hiking or by ferry. The next leg of the educational experience was spent in Torino, where we visited the University of Turin as well as a community pharmacy, Farmacia Borgarelli, and Molinette Hospital. We spoke to the pharmacists in both establishments, were given tours, and explained the process of pharmaceutical care.

Firenze, otherwise known as Florence, is one of those must-go-to cities in Italy, especially if you are in need of some leather. We had the weekend to spend gaining cultural experience along with exploring the vast marketplaces. The Firenze Duomo is not to be missed, and the best part is climbing the 463 steps up to the top of the dome. Be sure to pause beneath the ceiling on the way up to admire the frescoes. Once reaching the top of the dome, you have the ability to see the city at a whole different level. If climbing up those steps and back down was not enough cardio, there is also the opportunity to climb the bell tower right next to the cathedral with a mere 414 steps to the top.

On route to the next destination of Padua, we stopped in Verona for a day of sightseeing. The city of Verona may not be

Route for the PharMItalia journey starting in Malta traveling to Rome,

Siena, Pisa, Riomaggiore, Turin, Florence, Verona, Padua, and ending in

Venice.

MAP OF JOURNEY

Cinque

Terre

considered the city of love, but it is consumed with the story of Shakespeare’s Romeo and Juliet and includes Juliet’s balcony. Upon reaching Padua, we learned that the University of Padua is one of the oldest in Italy; unfortunately, they had to cancel our engagement and we were unable to learn about the pharmacy program there. However, we took the opportunity to visit the University and noticed they were having a career fair that day, which looked just like one you would see in Gainesville at our own University of Florida. In addition, we were given the task to visit one or two community pharmacies in the city to ask them questions about their practice.

A day excursion to Venice was a great ending to our adventure. While it is quite easy to get lost down the many paths, turns, and bridges in the city, that might be the best way to explore Venice. Of course, a gondola ride down the Grand Canal is necessary

when visiting the city on water. Plus, the Piazza San Marco is not to be missed, including touring the basilica and climbing the bell tower to see the city from all angles.

Pharmacy education in Italy differs from the American model in several distinct ways. There are two main degree programs offered, both of which are 5 years in length. The first is a pharmacy degree for those that want to go into community pharmacy, and the other is a clinical and technology program (University of Siena refers to it as Pharmaceutical Science and Technology) for those that want to go into industry. Both routes require completion of a thesis to graduate, as well as a six month period working in a pharmacy. For most universities, this period is done near the end of their studies. Those students that take the industry route can also choose to work in a community pharmacy upon completion of the program, even though they took a slightly different course load. Many of their exams are oral, but they only have about 27 to 30 for the whole program. Once they have completed the degree program, they earn a degree equivalent to a master’s degree in the United States and may choose to pursue a PhD later. If they would like to go the clinical route and work in a hospital, they must complete a postgraduate program that is 3-4 years in length. In the coursework, the main difference between Italy’s program(s) and ours is that Study abroad journey that included historical pharmacies,

universities, hospitals, group dinners, and cultural experiences.

PHARMITALIA

“It was intriguing to visit both

historic and current community

pharmacies to see both the

evolution of the profession and

the differences compared to

those in the United States.”

- Amanda Reidler

Orlando Campus

they do many more labs and learn to manipulate drugs and drug components while we work more on experiences outside the classroom in pharmacies and the community to work on our patient interaction. To enter pharmacy school in Italy one used to merely have to apply; now there is an examination to get into the program, but everyone that passes is usually accepted.

Overall, the study abroad adventure was a great success! This type of experience is a once in a lifetime opportunity and taking it is one of the best decisions that can be made during the time spent in pharmacy school. We have been enriched with a new take on pharmacy internationally, from the healthcare system and governmental standard differences to their pharmacy career options and schooling differences. The sites, views, and culture of Italy and Malta are all important and we learned a lot traveling around each city about the history of pharmacy as well as the countries themselves.

If anyone is interested in studying abroad or taking an international trip, the first step is taking the Global Health (PHA 5009) elective during fall semester. There are many opportunities this elective brings, from learning about health and healthcare throughout the world and the importance of interdisciplinary teams working together in all nations to having the chance to sign up for spring break mission trips, study abroad trips, or even an overseas rotation. Those of us who have been able to enjoy one of these experiences greatly encourage anyone remotely interested to sign up for the Global Health elective.

Community Pharmacy

Padua, Italy Juliet’s Balcony

Verona, Italy

Grand Canal, Venice, Italy Cinque Terre, Italy

St. Julian’s Bay

Malta

Community Pharmacy, Torino, Italy

Historic Pharmacies

Florence, Rome, and Siena

The U.S. Food and Drug Administration (FDA) Facebook page currently holds approximately 304,000 “likes,”

lagging behind the Centers for Disease Control and Prevention (CDC) Facebook page, which is edging

towards 482,000 “likes.” Meanwhile, the public’s interests sway toward other sources of

health and medical information. Dr. Mehmet Oz has rounded up a Facebook following of

5.5 million viewers, despite controversy over his product promotions. Even lesser known

health and wellness pages such as Everyday Health hold quadruple the amount of “likes”

as the FDA. Besides up-to-date medical and health knowledge, what can we, as healthcare

professionals, gain from following Facebook pages?

The FDA’s Facebook page, which appears to be in its 6th year of posts, states that the official source of FDA

information is available at www.fda.gov. Regardless, the page updates with new announcements nearly on a

daily basis. Announcements include disease state awareness, new drug approvals, food handling tips and

more. It even provides readers with FDA history information on throwback Thursdays. Despite the reputability

of these statuses, some of the lay-public seem to be skeptical and sometimes outright aggressive against

the informative updates. Comments on pages, such those found on the FDA’s Facebook page, can give

healthcare professionals insight into the fears, doubts, misconceptions and myths that are floating around

cyberspace for any credulous patient to see, believe and then practice.

A post on May 28th announcing the approval of Xifaxan (rifaximin) and Viberzi (eluxadoline) for irritable bowel

syndrome with diarrhea (IBS-D) received its first comment within 30 minutes.

“More drugs to poison us!” a reader protested.

FDA page moderators responded as any doctor or pharmacist might in the case of a patient who has

misconceived information.

“All drug products approved by the FDA have both benefits and risks. Part of how FDA determines a drug’s

safety is to assess whether its benefits outweigh its risks for the American public as a whole. We recommend

patients discuss their individual risks and benefits with their health care provider.”

Many posts accumulate complaints unconnected to the topic expressed. A March 20, 2015 post highlighting

National Native American HIV/AIDS Awareness Day, clinical trials and minority health, garnered a spectrum

of complaints about unsafe food and unrelatedly, fluorquinolone antibiotics ruining lives.

One commenter’s complaint under this topic resonates the mistrust, fear or lack of health education that

has established itself within the public.

“[What the heck]...most corrupt government program in America. What a shame. You should all be ashamed

we don't trust you...with our lives or our future generation. Get rid if the FDA...they literally do nothing good

but pass food and drugs that kill us. We can think for ourselves thank you.”

The Food and Drug Administration Facebook Page

What Facebook “Likes” and Comments Can

Teach Healthcare Providers

Written By: Kristine Friedel

The page is an open line of communication where information is divulged to the public and opinions are

welcome in return. Yet the FDA Facebook page does have a comment policy which highlights respectful

interaction and encourages focused, truthful comments. The policy states that “spreading misleading or false

information is prohibited.”

Despite policies which are meant to control information accuracy, there will always be people waiting to reply

with their own views. Additionally, many pages have no information-sharing policies and no policing for

evidence-based comments. So, what can we, as healthcare professionals, do about this? Nothing. The correct

question is what can we learn from this?

It can be nearly impossible to present the facts to an unwavering, unknown commenter who may

wholeheartedly believe in what they type or who may never see what you have retorted. By learning which

fallacies broadly exist we can work on answering the questions and dispelling the uncertainties that our own

patients may present with. We can impart the facts to the general public whenever we start to recognize

falsities broadly spread as healthcare information. By reading the comments, we can also learn of the disdain,

mistrust, or uncertainty that many commenters have for various health topics. While we may not be able to

curtail feelings of commenters online, just perusing these pages may help us understand and prepare for a

dialogue with our patients that share these beliefs.

Certainly not all remarks on the FDA’s Facebook page are from naysayers or need to be dismissed as

unsubstantiated remarks. Some commenters reply to updates with thanks, enthusiasm, support or “shares”.

“Sharing with many thanks,” wrote one commenter on July 31, 2015 regarding a post with a link discussing

The Food Safety Modernization Act.

In addition to the positive remarks that can be found sprinkled throughout the comment sections, a recent

survey did show that the FDA is in public favor—at least in terms of numbers. A July 2014 survey by the

Coalition for Sensible Safeguards questioned 700 adults. Results showed that the FDA was favorable in 58%

of the responses and unfavorable in 31%, while 11% had no opinion.

Although the survey showed a generally positive outlook on the FDA, the public seems disproportionally

focused on other sources for health information. “Like”-wise there appears to be an absence of interest in the

nation’s greatest overseers of public safety and health. Knowing that trustworthy and informative sources, like

the FDA Facebook page, are lacking widespread appreciation provides healthcare professionals with the

opportunity to promote these preferred pages by referring patients and friends to them. Moreover, being

aware of what information sources are most prevalent is imperative so that we are more likely to be able to

help patients weed through the information presented to them. Knowing what pages and health-related topics

are available and currently popular is the only way to promote or discourage them.

Next time you are on Facebook, I encourage you to check out the FDA page or any health-related

page. In addition to reading the articles or posts, analyze the commenter feedback

on these pages to gain insight into the thoughts and perceptions of those we

treat, interact with and care for. Look for the box that says how many “likes” the

page has, so that you can judge the popularity of the information. Just because it’s

a Facebook page, doesn’t mean it lacks impact on our patients or us, it means it can

have even more influence.

A few years ago, I worked as a technician at a grocery store pharmacy. One of our patients was a woman with cancer receiving an extremely expensive but life-saving medication. This patient had a single relative caretaker: a handicapped daughter, who arrived by taxi and could not understand medical information. Our patient relied fully on her daughter, her doctor, her insurance and our pharmacy to gain access to the medication that kept her alive. The daughter came again and again. One day, the patient’s insurance suddenly denied a claim for her medication. The prescription and insurance plan hadn’t changed – the insurance just stopped paying.

Pharmacists see grumpy, sick, tired patients and deal with finicky insurance daily, and bear them with longsuffering and smiles. But this was different.

The pharmacist called the insurance and was put on hold. He talked to some underlings and was put on hold again. The woman trying to pick up her mother’s prescription divulged that a taxi was waiting for her right now, outside the store.

The insurance customer service said prior authorization was required, which involved paperwork, and talking to the patient, who wasn’t even in the pharmacy.

He demanded a manager. He was put on hold again.

Someone else picked up and explained this was impossible.

The pharmacist demanded a manager again. And was put on hold.

More than 30 minutes passed this way. We triaged every customer at that point, with the pharmacist multitasking while on hold to crank out prescriptions and keep incoming patients as happy as possible.

Someone from the insurance company picked up again with the same message.

“You do not understand,” the pharmacist said gravely. “The patient will die without this medication.”

The patient’s daughter grew increasingly confused and upset.

After around 45 minutes on the line, a supervisor jumped on the line. The pharmacist politely explained how critical the medication was to this patients’ survival, and that treatment could not be delayed for any reason. Then he mentioned some insurance lawsuits in the news.

And the medication was approved again, like magic. We sighed with relief.

The pharmacist arranged a ride for the patient’s daughter and called the patient to explain everything. He did not say so, but there’s a good chance he saved the patient’s life that day.

Stories like this are ubiquitous but rarely heard. Pharmacists quietly perform critical healthcare services for patients – from fact-checking prescriptions against advanced clinical knowledge about drug interactions and allergies, to stumping for patients dealing with insurance issues, to counseling patients on medication use and health. Their keen eyes and knowledge are literally the last filter protecting patients seeking the healthcare they need.

But what is your pharmacist like? Do you know?

Most of us choose to fill our prescriptions at whatever pharmacy is closest, or whoever has a coupon or gimmick. Don’t feel bad – I have, too.

But maybe it’s pharmacists themselves that we should be picky about. Maybe we should choose our pharmacists with as much care as we pick our doctors.

Jonathan Parker Walton is a writer, Certified Pharmacy Technician, cofounder of the Inter-Professional Healthcare Coalition and student at the University of Florida College of Pharmacy.

Picky About Pharmacists By Jonathan Parker Walton

T he epilepsy drug lacosamide (brand name Vimpat®) was approved by the FDA on

Halloween of 2008, but the drug did not hit the market until late 2009—half a year after its

marketer intended. The reason for the delay is extraordinary, and one has to navigate to an

unusual place to learn the details:

The above is from a thread posted on bluelight.org, an online discussion board that focuses on

recreational drug use. The poster, who goes by the username “Hammilton”, seems like a very

informed individual but boasts no formal scientific credentials. He was able to singlehandedly delay

the release of a novel anticonvulsant because the DEA decided to make said anticonvulsant a

controlled substance, and the Controlled Substances Act requires the DEA to allow “any interested

person” to publicly object to the scheduling (i.e. prohibition) of a substance (21 U.S.C. §811(a))

To the best of this writer’s knowledge, there are zero firsthand human accounts of recreational

lacosamide use. If anyone has intentionally gotten high on lacosamide, they have not posted about it

in English on the internet. According to keyword searches, there are seemingly no lacosamide “trip

reports” on Bluelight, Erowid, Shroomery, Reddit or anywhere else that drug aficionados usually post

such things. In other words, there is no evidence that this substance has been abused by anyone in

the history of humanity. This is purportedly the reason why random citizen “Hammilton” decided to

lock shoulders with the DEA behemoth. And he seemed aware of the consequences of his actions.

“As such, if I fail and it is scheduled, I will have delayed epileptic's access to a needed medication for

no reason.”

I don't think I've mentioned it here before, but when the DEA published the notice

of proposal to place Lacosamide in Schedule V, I filed a comment asking for it to

not be scheduled. I'm pretty sure I was one of the only people to even file a

comment. I don't know if you realize this, but everyday citizens are able to file

comments, and even more: they get read. What's more is that everyday citizens are

able to ask for public hearings to be held; this is what I did. I filed the formal

paperwork to this end on Apr 30 or May 1. Unfortunately, this means that UCB has

been prevented from putting their drug on the market, which as I'm told, would

have happened the first week of May. (http://www.bluelight.org/vb/threads/439840)

Written By: Kemel Zaldivar

This concern was reiterated to him by another of Bluelight’s posters:

But was it a needless delay? Several of the last few drugs the DEA has scheduled have no apparent

history of human abuse. These include the anticonvulsant perampanel (Fycompa®), the sleep drug

suvorexant (Belsomra®), and the obesity drug lorcaserin (Belviq®). Each of these drugs, like

lacosamide, have novel mechanisms of action and do not significantly bind to the the receptors

typical of recreational chemicals (e.g. GABA receptors, opioid receptors, dopamine transporters,

NMDA receptors, etc.). During clinical trials, some subjects reported pleasant feelings as a result of

these chemicals; but in the years since these drugs have been released, there is not a trace of

evidence of prolonged abuse. The general public has had access to each of these chemicals for at

least a year and has not become addicted to them.

Moreover, the objection to the scheduling of these substances is not merely an academic exercise.

I work in a hospital pharmacy and we get many urgent orders for anticonvulsants. Most of these we

can send by pneumatic tube, and they reach the patient almost immediately. Lacosamide and

perampanel, on the other hand, have to be walked over to the patient because they are controlled

substances. This sometimes causes a delay; the patient receives the drug at a later time. Are we

OK with patients receiving anticonvulsants at later times than their physicians intended? Perhaps

(perhaps) some of us would be fine with that if the drug is likely to be diverted for abuse. But, to

reiterate, these drugs have likely never been abused by anybody anywhere.

An interesting corollary to the scheduling of drugs that have no history of abuse is that it could

create an artificial illicit desire for the drug. To wit, this can be seen happening with lorcaserin, the

anti-obesity drug which was pre-emptively listed in schedule IV. Here are some entries from

Bluelight:

Hammilton: well done you smug, self absorbed stupid b*****d. 3 - 12 months

needless delay for a drug that I need urgently just to satisfy your pumped up sense

of self importance - arent you a clever boy. You have no idea what you have done -

real people with real families will die from failing to control seizures which

lacosamide may wel have controlled. [sic]

So as I'm reading this, the DEA just Schedule IV'd a drug that can make you trip for 9 hours if you

take as little as double the daily dose at once.

I want to take too much Belviq now.

Hallucinations doesn't necessarily mean fun. But if it is, then I want some! Is it FDA approved yet?

It's on my list as well. It could make a psychedelic headspace without the visuals which would be

really enjoyable.

I now have some Belviq in my hot little hands… So should I just keep taking one every hour until I

feel euphoric, or what? (http://www.bluelight.org/vb/threads/676308)

The thread these comments appear in continues to list the testimony of people who sought

lorcaserin out simply because they saw it was a new prescription drug that had been added to

schedule IV. What one does not find—there or anywhere—is evidence of people habitually enjoying

lorcaserin. One finds, on the other hand, several accounts of people being disappointed by

lorcaserin. Arguably, the DEA created all of these instances. There is no reason to believe they

would’ve existed in the absence of a scheduling action.

My aim here is to call attention to the DEA’s recent pattern of scheduling prescription drugs that

have no real history of human abuse. This imposes a potentially unnecessary burden on patients

and on health care professionals. Doctors may be reluctant to prescribe these substances because

they do not want to attract the pendulous eye of law enforcement. Pharmacists may also be hesitant

to dispense these substances, or they may be unnecessarily encumbered. Since US law provides

an opportunity for “any interested person” to publicly oppose the scheduling of a new drug, health

care professionals—including pharmacists and pharmacy students—should monitor new scheduling

actions and actively participate in the public comment process. Not sure what to comment on?

Watch this space.

CONTRIBUTORS:

KRISTINE FRIEDEL

JUDITH JOHN

JACLYN KILSGAARD

TYLER SPINK

JONATHAN PARKER WALTON

KEMEL ZALDIVAR

The mission of The Quarterly Capsule is to engage and promote

student-to-student learning through current events in pharmacy.

If you would like to write or contribute for the next issue of The Quarterly Capsule, please

contact Jaclyn Kilsgaard (JaclynK21@ufl.edu) and/or Kemel Zaldivar (KZaldivar@ufl.edu)

Jac lyn K i lsgaard

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