Author: Bert McClary, RPh
The HAC met in Jefferson City on August 7
The Board met on July 12 in open session with several MSHP members present and participating.
By John Neill, PharmD Candidate 2018, and Courtney Kominek, PharmD, BCPS, CPE
Gabapentin and pregabalin are widely prescribed in chronic pain. Food and Drug Administration (FDA)-approved indications for gabapentin and pregabalin include post-herpetic neuralgia and epilepsy.1,2 In addition, pregabalin is FDA-approved for neuropathic pain (diabetic or spinal cord injury) and fibromyalgia.2 These gabapentinoids are frequently prescribed off-label for various reasons including post-operative pain, hot sweats, generalized anxiety disorder, and substance use disorders.3,4 Per the Controlled Substance Act, pregabalin is a Schedule V drug indicating it has the least likelihood for abuse among the 5 classes of controlled substances. Pregabalin was classified as a controlled substance based on the data from clinical trials. These trials showed that pregabalin causes positive psychic effects similar to alprazolam and diazepam, as well as acute euphoric effects seen at a higher proportion than expected.5 Gabapentin is not a controlled substance.3 Up until recently, gabapentin and pregabalin have been regarded as having low levels of abuse and being safe. This thought is rapidly changing and the reasoning behind this change will be described in this article.
Many drugs of abuse including alcohol, benzodiazepines, and non-benzodiazepine hypnotics display effects on gamma-aminobutyric acid (GABA) receptors.3 Gabapentinoids have structures that are similar to GABA, but they do not directly interact with GABA receptors or impact GABA uptake or production.6 It has been proposed that gabapentin may interfere with GABA metabolism, as well as cause the release of GABA allowing it to interact with its receptors.4 Gabapentinoids also reduce neurotransmitter release and the influx of calcium by binding to the alpha-2-delta subunit of voltage-gated calcium channels potentially causing their anticonvulsant, anxiolytic, and antinociceptive effects. It is believed, that not only do gabapentinoids cause euphoric effects most commonly attributed to GABA moderating drugs, but they may also cause dissociative effects through their interaction with the dopaminergic system.3 This dopaminergic relationship may also be the cause for the addictive potential of these drugs with the reward system being activated through this interaction. These dopaminergic effects are not typically seen with the other GABA modifying medications.3,4 In addition to the above effects associated with gabapentinoid abuse, other unexpected effects have been reported by abusers. These effects include relaxation and a high described as being similar to a high from marijuana, ‘zombie-like’ effects, and enhanced sociability.4
Gabapentinoid abuse is most common among the younger population, generally occurring in the 30s, on average. Risk factors for abusing gabapentinoids include a history of cocaine use, combination marijuana and benzodiazepine use at high rates, psychiatric patients, prisoners, and opioid abusers. The data for abuse rates for males vs. females is conflicting, with some studies showing higher rates in males, while others show higher rates in females. The prevalence of gabapentinoid abuse is much higher in this patient population and this problem has been on the rise in recent years. U.S. opioid abusers misused gabapentin and pregabalin as much as clonazepam and 2 times more than amphetamines. Gabapentinoid abuse is of particular concern in patients who currently abuse opioids or have a history of opioid abuse. Studies that have been done that have specifically assessed people with opioid use disorders and gabapentinoid abuse show pregabalin being abused at rates ranging from 3-68%, and gabapentin being abused at rates ranging from 15-22%. When comparing this to a study that showed the general population in the United Kingdom abusing pregabalin and gabapentin at rates of 1.1 and 0.5%, it shows you the alarming difference in rates of abuse between opioid use disorder patients and the general population.3Gabapentin dosing for post-herpetic neuralgia starts with 300 mg on day 1, 300 mg twice daily on day 2, and 300 mg three times daily on day 3, titrating up as needed to a max of 1800 mg/day; however, gabapentin may be dosed up to 3600 mg/day in divided doses for other conditions. Pregabalin dosing is recommended to start at 150 mg/day for all indications. This is typically divided into 2 to 3 doses per day. The general titration schedule is to increase to the max dose per indication based on tolerability and efficacy within 1 week. Max doses for pregabalin vary from 300 mg/day to 600 mg/day based on indication.2 Both medications require dosage adjustments for reduced renal function when creatinine clearance is below 60 mL/min.1,2.
Per individual case reports for gabapentinoid abusers, pregabalin abuse ranged anywhere between 800 to 7,500 mg per dose, with the median dose being 2,100 mg; and gabapentinoid abuse was anywhere between 1,000 and 12,000 mg per dose, with the median dose being 3,600 mg. These are typically single supratherapeutic doses when abused. Tachyphylaxis develops rapidly, so repeat abusers commonly increase the dose as they continue to abuse. U.S. poison centers have reported doses ranging up to 96,000 mg of gabapentin and 9,000 mg of pregabalin. No deaths occurred due to these high doses and outcomes were mostly mild to moderate. These reports indicate an advantageous adverse effect profile for these drugs; however, they are being seen on toxicology reports on an increasing basis. When pregabalin and gabapentin are used in conjunction with other central nervous system depressants, overdose deaths are more frequent.3
Typical abuse occurs via oral route, but intravenous routes, rectal plugging, smoking, and parachuting have been reported. Often times gabapentinoids are abused in conjunction with other drugs like alcohol, benzodiazepines, marijuana, opioids, lysergic acid diethylamide (LSD), selective-serotonin reuptake inhibitors, and quetiapine.3,4 People who abuse gabapentinoids typically acquire them with a legal prescription, from their family members or friends, or may purchase them online. Gabapentin on the black market ranges from $1 to $7 per pill.3
A concern related to gabapentinoid abuse is physical dependence and withdrawal symptoms. Withdrawal symptoms can be caused by sudden discontinuation of gabapentin or pregabalin. Withdrawal with gabapentinoids are very similar to what is seen with alcohol and benzodiazepine withdrawal, likely due to their effects on GABA.3 Symptoms that can result from alcohol and benzodiazepine withdrawal include anxiety, tremors, sweating, irritability, cognitive dysfunction, psychosis, and seizures, which can be life-threatening.7 Treatment for benzodiazepine and alcohol withdrawal involves using primarily benzodiazepines to help relieve symptoms. Benzodiazepine treatment for gabapentinoid withdrawal is ineffective, but fast relief can be attained by the administration of gabapentinoids. Re-administering gabapentinoids and slowly tapering the dose is the ideal way to treat gabapentinoid withdrawal.3
Some states have taken their own action to address this issue. The State Board of Pharmacy in Ohio made a rule effective on December, 1st 2016 requiring pharmacies, wholesalers, and prescribers to submit the specified dispensing, personal furnishing, or wholesale sale information on gabapentin to the Ohio Automated Rx Reporting System.8 In addition to the changes to gabapentin in Ohio, a rule went into effect in Kentucky on July 1, 2017 making gabapentin a Schedule V controlled substance resulting in the requirement of the administering and dispensing of gabapentin to be reported to Kentucky All Schedule Prescription Electronic Reporting (KASPER).9 It is highly likely that as time goes on more states will continue to adopt similar rules to help reduce the misuse and abuse of gabapentin.
Pharmacists are in a critical position to help reduce the spread of the abuse and misuse of pregabalin and gabapentin. Pharmacists can help raise awareness to this problem and make sure these medications are being used for legitimate purposes and that the doses are appropriate and do not exceed the maximum recommended dosages. It is important that pharmacists are aware of the warning signs of abuse such as frequent early refill request, patients requesting to pay out of pocket when they have insurance, multiple prescriptions for the same medication from different doctors, frequent transfers for that medication, and patients wanting their prescription early because it was ‘stolen or misplaced.’ We also need to pay particular attention to patients taking gabapentinoids who have substance abuse disorders, specifically people using opioids or with psychiatric issues.3
Author: Kyle Klindworth, UMKC SSHP Chapter President in Kansas City and Kaitlyn Lee, UMKC SSHP Chapter President in Columbia
This fall, UMKC SSHP had a membership drive that lasted throughout the first month of school and included many events. During the first week of classes, our school holds a "Lunch on the Lawn" event, which is essentially a student organization fair. At this event, we made a poster for our organization and had members of our executive board stand and give students information about joining the three organizations. We also held an informational SSHP general meeting early in the fall semester, to recruit membership from pharmacy students from all classes. During the 2016-2017 school year, across all three campuses, we recruited 120 members to join SSHP, MSHP, and the local chapters!
SSHP held the Clinical Skills Competition last October as a two-day event in an effort to increase student participation. The majority of students that partake in the event are typically fourth year students on rotations, so switching to a two-day event made the competition more successful. The first day was the case work-up. The judges reviewed the cases and the top teams were asked to present their cases on day two. This year we had ten teams of two students participate in the contest, and the winning team was sent to compete in the national competition at Mid-Year.
The UMKC SSHP Chapter also holds an annual “Residency Roundtable” in the Fall semester of the school year to provide students with tips for success related to residencies. This event facilitates the students' understanding of what is required to obtain a residency and what is expected of a resident. This year the event was held on October 1, 2016 with 42 student attendees. We invited current residents across the country to attend as well as their residency directors. Fifteen different residency programs were represented at the event. This provided students with a diverse group of residents and exposure to the many different areas of pharmacy. Diane McClaskey, RPh, BCPS gave a keynote presentation with useful tips for becoming a successful candidate for residency programs as well as helpful tips when interviewing, and the importance of residencies to the field of pharmacy. After the keynote, there was a panel discussion where the programs answered questions that students had regarding residencies followed by a lunch/networking session that lasted roughly 2 hours. Students were able to ask questions about programs and residency in general. After the networking session, there were two additional presentations about how to apply for residency programs and about the ASHP Mid-Year Clinical Meeting. Dr. Stephanie Schauner gave a presentation about PhORCAS and Dr. Barbara Kasper discussed ASHP Mid-Year Clinical Meeting tips. Both Dr. Schauner and Dr. Kasper gave insight into the general application process and interview information.
UMKC School of Pharmacy has three locations across Missouri, providing a unique opportunity for students to work with MSHP and the local affiliates/pharmacists involved in those communities. The goal of this project was to increase awareness of Health-System Pharmacists during National Pharmacy Week 2016. On the Springfield campus, SSHP members worked with the MSHP Secretary and Past-President to contact local radio and television stations and share public service announcements from ASHP. The PSA announcements were disseminated to four television stations and over 15 radio stations. For the Columbia location, the SSHP President (Columbia) worked with the President of Mid-Missouri SHP and the MSHP Secretary to provide these PSA announcements to local radio stations.
Last, but not least, UMKC SSHP continues to play a role in improving patient care within the community. One project that we have continued to be involved with is the Vial of Life project to further patient safety and continuity of care. The Vial of Life program allows our SSHP chapter to distribute vials to community members, particularly the elderly, at local health fairs and community events. Our members assist patients in completing an up-to-date home medication list and provide them with a sticker to place in their window so emergency personnel can find the list and obtain information about the patient's medication history. We believe that the Vial of Life project is a great way to help members of our community in a time when they need it most – during an emergency. We see this as a way to improve patient safety and provide continuity of care to patients, even when we are not physically with them. In total, we were able to distribute vials to over 120 patients in the community!
Author: Dip Patel, St. Louis College of Pharmacy SSHP Chapter President
St. Louis College of Pharmacy’s SSHP main focus over the past year was to provide an organization where students can exercise their leadership abilities while learning about Health-System pharmacy. Over the past year, we implemented 11 chair and co-chair positions to increase SSHP’s student involvement, increase the quality and quantity of our events, and encouraged students to take on more active roles. Our events have doubled with over 14 new events, and student leadership and involvement has increased within our organization, thus helping our members prepare for their future careers. STLCOP’s SSHP also had two students holding a national position – Joanna Huang was a member of the PSF Advancement of Pharmacy Practice and Dip Patel was a member of the PSF Leadership Development Advisory Group.
At the beginning of the year, SSHP promoted and participated in MSHP’s Fall meeting “Share the Vision.” Throughout the meeting, students were given the opportunity to attend many different sessions including topics of career and professional development. This meeting provided students with an opportunity to review their CV’s and meet with MSHP leaders. Our SSHP chapter emulated MSHP’s vision throughout the year to make our own events focusing on career and professional development for our students.
SSHP provided students with a tour opportunity at Mallinckrodt. The Nuclear Tour at Mallinckrodt provided insight to students as to how nuclear medicines are manufactured and what nuclear clinical pharmacists do on a daily basis. For most students, this was their first exposure to a nuclear medicine facility, and they were able to enhance their understanding of a potential career.
Our SSHP chapter also held the first-ever Practice Advancement Initiative (PAI) Week at St. Louis College of Pharmacy. It is one of ASHP’s best-known initiatives to promote and advance the profession of pharmacy. Many students on campus are unaware of PAI week, so SSHP’s goal was to educate students on PAI and discuss ways students can maximize our profession’s potential.
SSHP’s annual Clinical Skills Competition always provides students with a great professional and academic development opportunity through a clinical knowledge competition. We encouraged students to utilize their knowledge and compete for a chance to represent STLCOP at Midyear.
Throughout the year, we provided a three part series to introduce students to residencies. The first part focused on the underlying basics of residencies. The second part focused on how students can make a great CV that showcases their professional development throughout school. The third part of the series focused on having faculty critique students’ CVs such that they could make necessary improvements. This Residency Series was many students’ first exposure to residencies and provided both undergraduate and professional students information on what career options can be made possible with a residency.
Additionally, we gave students exposure to non-traditional pharmacy careers by having Poison Control and Home Infusion Lunch and Learns. They were able to interact with pharmacists who worked in these settings to improve their understanding on the daily functions of their positions. This was an educational experience for students that developed their knowledge and understanding on a unique career.
Towards the end of the year, we held an Aseptic Technique Lab. We provided hands-on lab experience with preparing IV bags. This will help students on hospital rotations and future careers.
Over the next year, we plan to continue having new seminars, as well as service and networking opportunities to inspire students to explore their passion in health-systems pharmacy.
As always, a lot is happening at the UMKC School of Pharmacy! Here are a few highlights to catch you up on recent activities at the school.
Outstanding Student Pharmacists! Once again, our chapter of the American Pharmacists Association- Academy of Student Pharmacists (APhA-ASP) continued to shine and bring national attention to UMKC! At the 2017 annual meeting of the APhA, our student chapter was recognized as the Division AA first runner up placing them in the top seven APhA-ASP chapters in the nation! Also at the APhA meeting, Elizabeth Rodman was recognized as the recipient of the nationally acclaimed Boyle Family Scholarship from the APhA Foundation, and Sara Massey was selected to serve on the APhA-ASP National Communications Standing Committee. Most recently, we had two participants in the competitive American Association of Colleges of Pharmacy Walmart Scholars Program: Sara Massey and Janna Brown. Many congratulations to all of our students who continue to do so well, and bring recognition to their school!
Outstanding Faculty! It is no wonder to me why our student pharmacists have been so successful. The answer is simple, they are led by outstanding faculty. In recent faculty news, we are proud that our own Dr. Jeremy Hampton was sworn in as the new President of the Missouri Society of Health Systems Pharmacists. Also in health system pharmacy, Dr. Andy Smith was named the Pharmacist of the Year by the Greater Kansas City Society of Health Systems Pharmacists. Dr. Lisa Cillessen and her colleagues at Jordan Valley Community Health Center received recognition from the American Diabetes Association for their Diabetes Education Program. We have another nationally recognized diabetes educator, and that is Dr. Andrew Bzowyckyj who was featured as a Member Highlight on the American Association of Diabetes Educator website. Also recognized on a nationally was the work that our own Dr. Kelly Cochran who in collaboration with her team from Mizzou and Lincoln University were recognized in the U.S. National Food and Agriculture 2016 Annual Report for their work to minimize health risks and avoid re-injury related to prescription medications for disabled farmers! In basic science research, Dr. Simon Friedman was awarded the 2017 UMKC Trustees Faculty Fellow Award as well as the UMKC NT Veatch Award for Distinguished Research and Creativity. And, Dr. Ashim Mitra was awarded the 2017 Dr. Roger Vogel Award for Pharmaceutical Research from the Association for Research in Vision and Ophthalmology. Congratulations to all of these faculty successes!
Dr. Beth Winans. The School of Pharmacy greatly misses our dear friend and colleague, Dr. Beth Winans who passed away after a long and courageous battle with cancer in December of 2016. Beth joined UMKC in 2007. Her practice was mostly at Truman Medical Centers’ Behavior Health Department, where she taught student pharmacists and medical teams. She was recognized nationally by the College of Psychiatric and Neurologic Pharmacists with the Innovative Practice Award, signifying her hard work, dedication and creativity in behavioral health.
Faculty Changes. Bitter sweet is how we describe our feelings for the upcoming retirement of Dr. Peggy Kuehl. Dr. Kuehl served the school for many years as the director of our community pharmacy residence program among many other teaching responsibilities in the school. We will greatly miss her, but we also wish Peggy well in her new adventures after retirement in the fall. The school is eagerly awaiting the start of new faculty joining the school. Dr. Diana Tamer will join us in the fall. Her expertise is oncology and her practice site will be at Shawnee Mission Health. We are grateful to our partners there who helped us recruit Diana and will welcome her into their practice. Also joining us in the fall is Dr. Melissa Palmer who has expertise in psychiatric pharmacotherapy. Her practice site will be at North Kansas City hospital. And, Dr. Sarah Oprinovich was recruited to serve as our new director of the community pharmacy residency program in collaboration with Balls Food Stores. Welcome aboard to Drs. Tamer, Palmer, and Oprinovich.
Student Changes. As always, the accomplishment that we are most proud of at UMKC is our graduates. May 2017 marked the celebration of 123 Pharm.D. graduates and five Ph.D. graduates. We continue to monitor the success of our graduates, and while we do not have all of the employment data for 2017 Pharm.D. graduates yet, it is clear that at least 113 of the 123 graduates had decided on positions as either full-time pharmacists or entry into residency programs prior to graduation! Our Ph.D. graduates continue to succeed as well going on to excellent research positions with a variety drug companies and post-doctoral fellowships at other universities. Student success is our number one and primary goal, and while we will miss having all of our graduates around the school, we certainly celebrate their successes and wish them well in their future endeavors. We are also eager to welcome in our new class of students in the fall. Like last year, we will admit up to 95 Pharm.D. students in Kansas City, and up to 30 each in Columbia and Springfield.
As always, you are all welcome to visit the school anytime at our sites in Kansas City, Columbia, and/or Springfield. We also appreciate your assistance in identifying any students who might be interested in pursuing pharmacy careers. Just let us know, we love to talk to anyone about our great profession! Best wishes to everyone in MSHP!!
Russell B. Melchert,Ph.D.,R.Ph
Dean of the School of Pharmacy and Professor, Division of Pharmacology and Toxicology
The 2016-2017 academic year has ended at St. Louis College of Pharmacy. On May 12-13, we celebrated our students’ accomplishments at our 149th Commencement, and we welcomed the doctoral class of 2017 into the profession of pharmacy. We also celebrated a milestone with our undergraduate students. For the first time, we awarded Bachelors of Science to students completing their undergraduate studies in the College’s new curriculum implemented in fall 2014.
The end of the year also provides an opportunity to reflect on all we have accomplished as a community. Nearly three years ago, we began the largest expansion project in the College’s history by breaking ground on the Academic and Research Building (ARB). Today, after adding more than 400,000 square feet of space to campus, we are preparing to open the Recreation and Student Center (RAS).
The RAS will be a hub of student activity, and the building has been thoughtfully designed to support student life. Students will benefit from one-stop access to study space, academic and personal support resources, dining, and fitness and recreation. The building is the new home to the College’s intercollegiate athletic programs and offers student-athletes a competition gymnasium and training facilities. Faculty and staff are beginning to move into offices and students are beginning to explore the building.
As these physical changes to our campus unfold, our faculty are taking steps forward through collaborative research.
The recently established Center for Health Outcomes Research and Education, led by inaugural Director Scott Micek, Pharm.D., associate professor of pharmacy practice, will bring together faculty across campus to focus on six key areas for improvement – nonadherence, delayed evidence-based treatment practice, antibiotic misuse, medication errors, suboptimal generic use and mismanaged polypharmacy. The effort was made possible by a generous contribution from Express Scripts Foundation, which in part, provided funds for the establishment of the center.
The Center for Clinical Pharmacology, led by Director Evan D. Kharasch, M.D., Ph.D., and Co-Director Karen Seibert, Ph.D., is continuing to make progress toward fulfilling its vision. On May 1, the center welcomed its first two faculty researchers, Ream Al-Hasani, Ph.D., and Jordan G. McCall, Ph.D. Recruitment is underway for three more researchers, who will hold academic appointments at both the College and Washington University School of Medicine in St. Louis.
This is an exciting time at St. Louis College of Pharmacy! I hope you will visit campus often and see our progress.
Bruce R. Canaday, Pharm.D., FASHP, FAPhA
Dean of Pharmacy and Professor
P.S. The College is hosting the 2017 Reunion Celebration on Saturday, Nov. 11. Join us on campus for a family-friendly reception, Gold Alumni luncheon and a tour of the new buildings. More information is available online at stlcop.edu/reunion.
SB 501 was signed by the Governor on July 14 and will become effective on August 28 or other specific dates. Provisions include a statewide protocol for distributing an opioid antagonist; a procedure for prescribing, distributing and administering epinephrine injectors outside of usual prescription requirements; compliance with Medicare Conditions of Participation as the qualifying basis for a hospital license; clarifying a protocol relationship for pharmacists administering vaccines; allowing BOP to expend funds for a drug take-back program for CII and CIII controlled substances; and changes to physician assistant language related to dispensing drugs.
Click here to read the Senate Bill 501.
The Strategic Planning Committee met on June 24 and included scope of practice legislation and technician legislation proposals as its regulatory priorities for the coming year. A third priority will be enhancing relationships with the Missouri Hospital Association.
The HAC has not met since the last Newsletter was published. The next meeting in August will include a review of the committee’s progress and structure and discussion of future activities.