The Kentucky Pharmacist - November/December 2019

Vol. 14 No. 6 November/December 2019

THE KENTUCKY

PHARMACIST Official Journal of the Kentucky Pharmacists Association

INSIDE: Legislative Conference Recap Complete CE Requirements for 2019 Happy Holidays from KPhA

The Voice of Pharmacy in Kentucky

TABLE OF CONTENTS FEATURES Legislative Conference Wrap Up |6|

On the Cover Mission Statement: The mission of KPhA is to advocate for and advance the profession through an engaged membership.

Editorial Office: ©Copyright 2019 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association.

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Photos from the 2019 Legislative Conference

IN EVERY ISSUE President’s Perspective |3| My KPhA Rx |8| November CE Article |10| November Quiz |13| November CE Answer Sheet |14| December CE Article |16| December Quiz |24| December Answer Sheet |25| Pharmacy Policy Issues |26| Campus Corner |27| New KPhA Members |29| Pharmacy Law Brief |30|

Publisher: Mark Glasper Managing Editor: Sarah Franklin Editorial, advertising and executive offices at 96 C Michael Davenport Blvd., Frankfort, KY 40601.

Phone: 502.227.2303 Fax: 502.227.2258.

Email: info@kphanet.org.

Website: www.kphanet.org.

ADVERTISERS APSC|4| PTCB |15| EPIC |29| APMS |31| Pharmacists Mutual |32| Cardinal |33|

|2| Kentucky Pharmacists Association | November/December 2019

PRESIDENT’S PERSPECTIVE Well, we now know how the next four years will be legislatively in the Commonwealth, with the statewide elections in the books. With a Democratic Governor and Lieutenant Governor, but the remaining state leadership being Republican, and the Senate and House both in the Republican leadership, it is yet to be seen how this will work. That being said, your KPhA has been hard at work meeting and discussing the issues with GovernorElect Andy Beshear and the, Senate and House leadership regarding Pharmacy Benefit Managers operating in our state. We are also crafting a bill to be introduced in the state House of Representatives to begin a push for pharmacist compensation for clinical activities/services with their patients that are within the pharmacist scope of practice.

“KPhA has been hard at work meeting and discussing the issues with Governor-Elect Andy Beshear and the Senate and House leadership regarding Pharmacy Benefit Managers...”

November 1-2. With more than 350 attendees, including a great student turnout the programming included roundtable discussions and 7.5 hours of continuing education. Additionally we conducted the House of Delegates where I’m proud to say we we finalized KPhA’s position statement on “Telepharmacy”.

Don Kupper President, KPhA

KPhA’s Telepharmacy Position Statement KPhA supports the use of telepharmacy technology to provide patient access to the services of a pharmacist when the use of such technology benefits the patient and community. KPhA supports the use of telepharmacy technology when limited to suitable functions of pharmacy operations and patient care that improve patient outcomes, expand access to healthcare, and enhance patient safety when direct on-site pharmacist oversight is unachievable.

Regarding remote dispensing as a specific activity accomplished through the use of telepharmacy technology, KPhA supports the following limitations when the act of dispensing is completed by a certified pharmacy technician under remote supervision of a pharmacist, and not under immediate supervision as defined in KRS 315.010.

Geographical restrictions: A remote dispensing site shall not be authorized if a community retail pharmacy is located within 20 miles of the proposed remote dispensing site.

Don Kupper, KPhA President, discusses advocacy issues with students during the Legislative Conference. .

Supply and Demand: Prior to authorizing the license of a remote dispensing site, the Board of Pharmacy shall consider the availability of pharmacists, the population of the community and the community’s need for the service. A remote dispensing pharmacy may fill a maximum of 125 prescriptions per day over one year average.

Certified Pharmacy Technician Qualifications: A remote dispensing site shall be staffed with a certified pharmacy techWe hosted a Sip & Mingle networking event, November nician with at least 2000 hours of community or dispensing 7 in Northern Kentucky with our Northern Kentucky pharmacy technician experience in Kentucky after having acPharmacists Association members, future members and quired certification.

our host AstraZeneca. I appreciated the help of NKY Supervision limitations: A pharmacist performing remote Chair Paula Miller and Secretary Suzi Francis who re- supervision shall not supervise more than one (1) remote discruited the great crowd of attendees. pensing site and a “home pharmacy” or affiliated parent comKPhA had our Legislative Conference in Lexington,

pany shall not own more than one (1) remote site.

KPhA sends email announcements weekly. If you aren’t receiving: eNews, Legislative Updates and other important announcements, send your email address to info@kphanet.org to get on the list. |3| www.KPHANET.org

|4| Kentucky Pharmacists Association | November/December 2019

At the holiday season our thoughts turn gratefully to those who have made our progress possible. It is in this spirit that we say...Thank you and best wishes for the holidays and Happy New Year!

In observance of the holidays KPhA headquarters will be closed on November 28, 29, December 24, 25, 31 and January 1. The offices will resume regular business hours on January 2.

Give Back with AmazonSmile!

Did you know that Amazon donates 0.5% of the price of your eligible AmazonSmile purchases to the Kentucky Pharmacy Education and Research Foundation Inc.? This contribution supports our educational initiatives.

All you need to do is: Step One: Go to Smile.Amazon.com (https://smile.amazon.com/ch/31-1012133) Step Two: Choose the Kentucky Pharmacy Education and Research Foundation Inc. as your charity.

Step Three: Whenever you are shopping, start at Smile.Amazon.com Take advantage of this easy way to shop and help the KPERF! |5| www.KPHANET.org

Happy Holidays Legislative Conference Wrap Up November 1-2 | Griffin Gate Marriott | Lexington The Legislative Conference was held November 1-2 at the Griffin Gate Marriott Resort & Spa in Lexington. We hosted over 350 attendees! KPhA offered 7.5 CE hours, including topics such as Advocacy 101, Advocacy Topic Roundtables, USP Update, Challenges and Opportunities in the 340B Space and a panel on Pharmacists Role in Providing Care to Our Patients—Controlled Substances. The 2020 Legislative Agenda was presented by Government Affairs Committee Co-Chair, Richard Slone and the House of Delegates approved the KPhA policy statement on telepharmacy, which can be found on the KPhA website and on p.3 of this issue. Special thank you to Kroger for sponsoring breakfast and NACDS for the sponsoring the students.

Richard Slone, KPhA Board of Directors, commenting during the House of Delegates meeting.

Chris Palutis, KPhA Chair addresses the House of Delegates.

Brooke Hudspeth, KPhA Secretary leads discussion during the legislative roundtables.

Finding the Balance Seminar On October 12, Northern Kentucky physicians, pharmacists and nurses joined together at a KPhA-sponsored continuing education event titled “Finding the Balance: Providing Pain Management in the Era of Overdose Crisis”. Provided through the CDC Crisis One grant funding program, the event covered topics such as the 2016 CDC Opioid Guidelines, appropriate opioid titration, caring for displaced patients, and harm reduction in community practice. Additionally, invitees were able to spend lunch in conversation with an invited speaker who had previously suffered from opioid use disorder (OUD) and is now in long-term recovery.

Participants in the seminar received 4.0 hours of House Bill One CME or CPE for the event, which was free to participants. Discussion among the group included how to best work together across different disciplines: What is the best mode of communication for physicians and pharmacists to discuss concerns about a patient? How does the tension between regulatory responsibilities and patient care affect different modes of practice? Louisville-area pain and addiction physician James Murphy presented on ways that healthcare providers across the spectrum can compassionately care for patients who have been displaced from current prescribers, and what our responsibilities are in weighing risks and benefits of opioid medications.

Planning for the 2020 regional seminars is underway. KPhA and its grant partners anticipate holding 4-6 regional events for the upcoming year. If you would like to participate in or recommend someone for our interprofessional steering committee, please contact jessica@kphanet.org; the group will be meeting remotely once to twice per month. Healthcare professionals in all settings need to be part of the solution in helping Kentucky reverse overdose mortality, and we hope that you’ll join us at an event next year to learn more about ways to help! |6| Kentucky Pharmacists Association | November/December 2019

Breakfast Sponsor

Student Sponsor

|7| www.KPHANET.org

MY KPhA Rx Opportunities Abound in Annual Survey Results

By Mark Glasper KPhA Executive Director/CEO Thanks to everyone – KPhA members and nonmembers – who completed our recent Annual Pharmacist Survey.

KPhA member Lavanya Wijeratne Peter was the lucky winner of our $100 gift card drawing just for completing the survey. She was selected at random November 11 live on the KPhA Facebook page.

We also saw balanced responses among pharmacy practice settings. Leading the way were Community/Independents at 34% followed by Hospital/Health System at 19% and Chain/Retail at 11%. These results also had an impact on the ranking of concerns by pharmacists and ultimately what you want and need from KPhA. Advocacy Rules

We had almost double the responses to the survey compared with last year’s annual survey, and you had a lot to tell us! From advocacy and workplace issue concerns to wanting more CE and networking opportunities, you let us know your most pressing needs and wants.

Let’s Dig in

PBM reform and action regarding DIR fees and reimbursements clearly outdistanced all other responses.

With that said, provider status stood out among all remaining areas in which you want to see KPhA make a difference.

Other legislative concerns expressed by you included, in order of importance, Medicaid Carve Out, Medical Marijuana, Mail Order Prescriptions, CBD, Telepharmacy and USP 795, 797 and 800.

Demographics were very balanced. In fact, 49% of respondents were male which matched exactly the percentage of female respondents. Age of respondents was dispersed as well with ages 25-34 receiving the largest block of 30% while the 60-69 age group responded with 24%. All other age decades responded in the single digits. Fifty-four percent of respondents were from the Central region of Kentucky while all other respondents were equally dispersed among the Northern, Eastern and Western regions.

You also ranked KPhA’s advocacy efforts as the toprated benefit of membership. This activity will become increasingly important in the upcoming 2020 legislative session where we will focus our advocacy activities on PBM reform and a Medicaid Carve Out while advocating for provider status or, as we now refer to the activity as, compensation for professional services within pharmacists’ scope of practice.

An outstanding total of 60 pharmacists told us they know their state legislators, which is so important to our advocacy efforts. If you haven’t already, please reach

|8| Kentucky Pharmacists Association | November/December 2019

out to your state legislators and invite them to visit you KPhA initiated our signature Sip & Mingle networking at work – no matter your practice setting. We have talk- events this year to great success and we intend to carry ing points for you to share with them as we step up our the concept further in 2020. activity leading up to the 2020 legislative session.

Insurance Needs are Real Improve Working Conditions

Many of you wrote passionately in your responses about how retail working conditions must improve. From bathroom and lunch breaks to the ever-increasing number of scripts to fill, you communicated the pressure under which you work. You expressed the need for your Board of Pharmacy to set parameters around working conditions. We will voice your concerns to them.

You should know your KPhA Board of Directors have heard your pleas. With the number of layoffs and the cutback of hours we’re seeing, your Board is brainstorming ideas on how to assist pharmacists who have lost their jobs, such as, free membership. We firmly believe you will see the benefit of membership and the difference KPhA makes in the lives of pharmacists.

More CE & Networking

Despite all of the demands on your time, you expressed an appetite for additional CE opportunities delivered live, in webinars and in print. You also want KPhA to come to where you live – to our various regions throughout the Commonwealth. Please know we will reach out to our districts and local associations to improve CE programming.

You again expressed the need for insurance – for yourselves and your employees. Not only health insurance – 70% expressed a need for dental insurance; 59% for vision insurance; 53% for life insurance and 47% for disability insurance. Rest assured KPhA is actively researching plans and what will be most cost effective for you and your employees.

Thanks, again, to all of you who completed our Annual Pharmacist Survey. We hear your concerns and will use your input to make KPhA more effective in all of our pursuits as well as an indispensable resource to you and all pharmacists throughout Kentucky.

jobs.kphanet.org THE location for pharmacy job seekers + employers for targeted positions.

You also indicated networking events are a great way to meet colleagues, learn and find new job opportunities. |9| www.KPHANET.org

November CPE Article E-Cigarettes: Growing Popularity and Related Health Consequences By: Keaton Creed PharmD Candidate, Sarah Raake PharmD MSEd BCAP LDE, Katie Leslie PhD MS The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-0000-19-011-H01-P &T 2.0 Contact Hours (0.2 CEU) Expires 11/21/22

KPERF offers all CE articles to members online at www.kphanet.org

Learning Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: 1.

Describe the risks associated with smoking e-cigarettes.

2.

List the signs and symptoms of nicotine overdose.

3.

Identify ingredients that pose a risk to human health.

4.

Recognize the signs and symptoms of vaping related respiratory illness.

5.

Summarize the recent changes in federal cannabis and e-cigarette regulation.

Introduction E-cigarettes are commonly referred to as “vaping” or “electronic nicotine device systems” (ENDS). These devices have become increasingly popular alternatives to traditional cigarette smoking in recent years. The Surgeon General estimates more than 3.6 million of the nation’s youth were using a form of vaping product in 2018.¹

garding the health risks of these products. These regulations are the first step in developing future FDA regulation.² Nicotine

The statement that e-cigarettes are safer than smoking cannot be confirmed until further investigation into ENDS products have been completed. However, the aerosol emitted by ecigarettes can contain ingredients known to be harmful to These battery-operated devices heat liquid nicotine (and other human health. This includes nicotine. additives) into an aerosolized inhalant. Devices can range According to manufacturer websites, cigarettes can contain 8 from the size of a small USB to a larger handheld tank sysmg to as high as 20 mg per cigarette depending on the brand. tem. Users can purchase their vaping liquids from online E-liquids are marketed at 0 mg/mL, 6 mg/mL and doses constores, smoke shops and occasionally a variety of nontinued up to as high as 36 mg/mL. A 1 ml cartridge lasts a regulated “street” sources. variable number of inhalations. Many e-cigarette companies Due to the growth in popularity of these products, the Tobac- make claims that 1 mL of liquid can last anywhere from 100co Control Act was expanded to cover all types of tobacco 200 inhalations. The user specific inhale rate and captivity of and nicotine usage as of August 8, 2016. This Act allowed e- the cartridge makes nicotine consumption difficult to calcucigarettes to be regulated by the Food and Drug Administra- late. tion. This regulation includes the “manufacturing, importing, As of September 1st, 2019, the “National Poison Data Syspackaging, sale, and distribution of e-cigarettes”.² Certain requirements of the “Federal Food, Drug, and Cosmetic Act” tem, American Association of Poison Control Centers” has also apply to any site that is deemed a manufacturer. This can had 3,583 cases of liquid nicotine exposure.³ Some of those be interpreted to include “vape-shops” if the store is preparing liquid nicotine exposures resulted in children experiencing extreme nausea and vomiting requiring an emergency room or mixing e-liquids. visit.³ ENDS products currently on market were given compliance Young children are not the only ones potentially harmed by dates to meet certain requirements by the FDA. These renicotine. Nicotine exposure in adolescents has been associatquirements included the submission of tobacco health documents and ingredient listings, inclusion of warning statement ed with the inhibition of brain development involved in learnon product labels for nicotine and registration of ENDS retai- ing, attention and mood. Nicotine use in pregnancy can result lors and enterprises. In June 2019, most of the deadlines had in multiple adverse health consequences including sudden infant growth syndrome.¹ Since nicotine content is difficult to passed.² measure, it is recommended that pregnant patients avoid any There is little known about the long-term effects of ENDS and all nicotine exposure. use. The FDA is currently trying to gather information re-

|10| Kentucky Pharmacists Association | November/December 2019

Many delivery techniques for using cannabis have become popular (including vaping) despite safety concerns. One study Benzene is an additive found in some vaping products. It is a has shown a decreased toxin emission for vaping compared to known volatile organic compound. Flavorings such as diace- traditional smoking.7 However, the concentration of THC tyl are added into vaping liquids. Diacetyl has been recently found in vaping methods is elevated and could have unknown linked to multiple respiratory disorders including the severe effects on both psychological and respiratory systems. Lung respiratory illness bronchiolitis obliterans.4 This illness results surfactants have been compromised by cannabis smoke conin fibrotic deposits in the respiratory system. Diacetyl has also taining approximately 1% THC. 7 been shown to correlate with fixed obstructed airflow readTHC has shown promising therapeutic results for conditions ings. Data suggests that diacetyl is the causative agent for these respiratory illnesses, but it is unclear if it could simply be such as epilepsy, anxiety and sleep disorders.8 However, the negative effects of cannabis use increased in recent years. This a marker for another agent.4 has paralleled the increasing concentration and potency of Injuries cannabis products.8 Further investigation into the effects of increased THC concentrations found in cannabis vaping is The CDC has reported 1,080 e-cigarette related lung injury needed. cases from 48 states and 1 US territory as of October 1, 2019.5 Of those cases, 18 deaths were confirmed and 80% of ill paA Pharmacists Role tients were under 35 years of age. All patients reported a varieThe pharmacy profession is expanding every day to encomty of e-cigarette or vaping usage and many of those patients pass protocols such as smoking cessation. When screening (78%) reported vaping THC. 5 patients for tobacco usage, consider adding the question, “Do Research is required to determine the source of this outbreak, you use or have used an e-cigarette or vaping device?” If the but no infectious cause has been reported. This leads response is yes, consider educating the patient about the risks healthcare professionals to question the potential cause is a of all forms of tobacco and nicotine use especially in adolesdevice, brand, method or chemical. 5 cents. Patients should be made aware of the current statistics and the unknown effects of long-term vaping. Encourage and Patients in these cases have reported various times of onset ranging from a few days to several weeks.5 Symptoms include motivate patients to consider quitting and provide them with access to materials to quit. fever, weight loss, vomiting, diarrhea, shortness of breath, Additives

chest pain, nausea, cough, abdominal pain, fatigue.5 Patients Patients currently vaping or considering vaping should be experiencing these symptoms and who have been using a vap- aware of the dangers of nicotine overdose, especially in chiling device should consider visiting a physician. dren and adolescents. Nicotine is addictive and should be kept out of the reach of children to avoid nicotine overdose. NicoThe CDC has partnered with state and federal agencies to activate the Emergency Operations Center for 24/7 assistance tine can be absorbed through the skin, gloves or other protecin identifying the cause(s) of this outbreak. 5 The CDC recom- tive materials should be used when handling liquid nicotine.

Follow the manufacturers label for proper disposal instrucmends abstinence from all nicotine containing products but tions.³ Many e-cigarette companies make claims that 1 mL of specifically vaping products until further investigation into these outbreaks have been completed. If you stopped smoking liquid can last anywhere from 100-200 inhalations. The user specific inhalation rate and capacity makes nicotine consumpand started vaping as a form of tobacco cession, do not start tion difficult to calculate. Signs and symptoms of nicotine .5 smoking cigarettes again overdose occur within the first hour of exposure and include but are not limited to; dehydration, headache, anxiety, nauTHC sea, vomiting, dizziness and tremors. Some severe cases can Cannabis has become legal in many US states and worldwide. include seizures, coma, breathing difficulties and respiratory Congress approved the Agriculture Improvement Act of 2018 failure. Inform patients, “You can reach your local poison (2018 Farm Bill) in December 2018. Cannabis and derivatives control center by calling the Poison Help hotline: 1-800-222with no more than 0.3% concentration of THC were removed 1222. To save the number in your mobile phone, text POIfrom the Controlled Substances Act and labeled as “hemp” SON to 797979.”³ products. Before 2018, cannabidiol (CBD) oil and marijuana Conclusion were classified as having no medical benefit and high abuse potential (Schedule I controlled substances).6 The complications of long-term e-cigarette usage are still unIn Kentucky, all marijuana possession, trafficking and produc- known. Pharmacists and healthcare workers should report tion are criminalized. Marijuana possession in Kentucky can vaping related adverse effects to the FDA. Regulatory actions result in fines, misdemeanor charges and even felony charges. are being developed by a combination of federal and state authorities but more data on e-cigarettes are needed.9 PharmaHowever, hemp derived products are legal in Kentucky.

Those interested in cultivating and/or processing hemp seeds, cists should inform patients of the dangers of unregulated plants or leaves must obtain a license from the Kentucky De- “street” sources and inform patients of clinically sound tobacpartment of Agriculture. Failure to obtain a license will result co cessation tools such as nicotine replacement therapy. in the same penalties as illegal marijuana.

|11| www.KPHANET.org

References 1. U.S. Department of Health and Human Services. E-Cigarette Use Among Youth and Young Adults. A Report of the Surgeon General.

Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2016.

2. Products for the Overview of the Family Smoking Prevention and Tobacco Act. U.S. Food and Drug Administration. https://www.fda.gov/tobacco-products/rules-regulations-andguidance/family-smoking-prevention-and-tobacco-control-actoverview. Accessed October 14, 2019.

3. American Association of Poison Control Centers (AAPCC) - Tobacco & Liquid Nicotine. https://www.aapcc.org/prevention/tobacco-liquid-nicotine/. Accessed October 9, 2019 4. Clapp PW, Lavrich KS, Heusden CAV, Lazarowski ER, Carson JL, Jaspers I. Cinnamaldehyde in flavored e-cigarette liquids temporarily suppresses bronchial epithelial cell ciliary motility by dysregulation of mitochondrial function. American Journal of Physiology-Lung Cellular and Molecular Physiology. 2019;316(3). doi:10.1152/ajplung.00304.2018.

https://www.cdc.gov/tobacco/basic_information/ecigarettes/severe-lung-disease.html. Published October 3, 2019. Accessed October 9, 2019.

6. FDA. Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance the agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabisderived products. Apr 2, 2019.

7. Meehan-Atrash J, Luo W, Mcwhirter KJ, Strongin RM. Aerosol Gas-Phase Components from Cannabis E-Cigarettes and Dabbing: Mechanistic Insight and Quantitative Risk Analysis. ACS Omega.

2019;4(14):16111-16120. doi:10.1021/acsomega.9b02301.

8. Lafaye G, Karila L, Blecha L, et al. Cannabis, cannabinoids, and health. Dialogues Clin Neurosci 2017;19:309–16 9. Sharpless, N. (2019). How FDA is Regulating E-Cigarettes. [online] U.S. Food and Drug Administration. Available at: https://www.fda.gov/news-events/fda-voices-perspectives-fdaleadership-and-experts/how-fda-regulating-e-cigarettes Accessed October 16, 2019.

5. Outbreak of Lung Injury Associated with E-Cigarette Use, or Vaping. Centers for Disease Control and Prevention.

Save the Date!

KPhA Annual Meeting & Convention Louisville Marriott Downtown June 11—14, 2020

|12| Kentucky Pharmacists Association | November/December 2019

November 2019— E-Cigarettes: Growing Popularity and Related Health Consequences 1. The FDA is involved in regulating which of the following areas of e-cigarette manufacturing?

A. Importing B. Distribution C. Sale D. All the above 2.

A. B. C. D.

Benzene is a known Volatile Organic Compound Flavoring Volatile Inorganic Compound Non-Volatile Compound

10. Adverse side effects associated with ENDs should be reported to the CDC and FDA because?

A. They want to ban ENDs B. Data gathering is an important step in understanding the effects of long-term ENDs use C. ENDs cause cancer, we just do not know which kind of cancer D. Medical professionals and patients should not report adverse events

3. Vaping illnesses have presented with symptoms including?

A. Weight gain and constipation B. Excitability and paranoia C. Fever, weight loss and shortness of breath D. Hyperthermia 4.

A. B. C. D.

Which of the following is true regarding hemp in Kentucky?

Cultivation does not require a license Hemp cultivation requires a valid license Hemp derived products are legal in Kentucky Hemp derived Products are illegal in Kentucky

5. This FDA rule was expanded to cover e-cigarettes?

A. Cigarette Act B. Nicotine Act C. Tobacco Control Act D. Smoking Act 6.

A. B. C. D.

What are the risks associated with smoking ENDs? The risks of long-term ENDs use are unknown ENDs use will cause lung cancer ENDs are worse than regular cigarette smoking ENDs are a great choice for smoking cessation

7.

A. B. C. D.

How should liquid nicotine should be disposed of?

Throw it in the trash Rinse it down the sink By following package specific directions Flush it down the toilet

8.

A. B. C. D.

Nicotine overdose symptoms include which of the following?

Nausea and vomiting Dizziness and tremors Breathing difficulties All the above

9. What is the name of the bill that allowed hemp to be removed from the Controlled Substances Act? A. 2018 Farm Bill B. 2014 Farm Bill C. 2018 Hemp Bill D. 2014 Hemp Bill

Friendly reminder to check CPE Monitor to ensure all of your credits are listed for 2019! https://nabp.pharmacy/cpe-monitor-service/ |13| www.KPHANET.org

This activity is a FREE service to members of the Kentucky Pharmacists Association.

The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

Expiration Date: 11/21/2022 Successful Completion: Score of 80% will result in 2.0 contact hour or .2 CEUs. TECHNICIANS ANSWER SHEET November 2019— E-Cigarettes: Growing Popularity and Related Health Consequences (2.0 contact hours) Universal Activity # 0143-0000-19-011-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 7. A B C D 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. A B C D Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________

PHARMACISTS ANSWER SHEET November 2019— E-Cigarettes: Growing Popularity and Related Health Consequences (2.0 contact hours) Universal Activity #0143-0000-19-011-H01-P Name _______________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: ABCD 3. A B C D 5. A B C D ABCD 4. A B C D 6. A B C D

7. A B C D 8. A B C D

9. A B C D 10. A B C D

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy

Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted.

|14| Kentucky Pharmacists Association | November/December 2019

Have an idea for a continuing education article? WRITE IT! Continuing Education Article Guidelines The following broad guidelines should guide an author to  completing a continuing education article for publication in The Kentucky Pharmacist.  



Average length is 4-10 typed pages in a word processing document (Microsoft Word is preferred).



Articles are generally written so that they are pertinent to both pharmacists and pharmacy technicians. If the subject matter absolutely is not  pertinent to technicians, that needs to be stated clearly at the beginning of the article.



Article should begin with the goal or goals of the overall program – usually a few sentences.



Include 3 to 5 objectives using SMART and measurable verbs.



Feel free to include graphs or charts, but please submit them separately, not embedded in the text of the article.



Include a quiz over the material. Usually between 10 to 12 multiple choice questions.

Articles are reviewed for commercial bias, etc. by at least one (normally two) pharmacist reviewers.

When submitting the article, you also will be asked to fill out a financial disclosure statement to identify any financial considerations connected to your article.

Articles should address topics designed to narrow gaps between actual practice and ideal practice in pharmacy. Please see the KPhA website (www.kphanet.org) under the Education link to see previously published articles.

Articles must be submitted electronically to the KPhA director of communications and continuing education (info@kphanet.org) by the first of the month preceding publication.

|15| www.KPHANET.org

December CPE Article Pain Management in the Pregnant Patient: A Review By: *Elisa Greene, PharmD, BCACP, Adam Pace, PharmD, Lindsay Hahn, PharmD, BCPS Associate Professors of Pharmacy Practice, Belmont University *Corresponding Author The author declares that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-0000-19-012-H01-P &T 2.5 Contact Hour (0.25 CEU) Expires 11/21/22

KPERF offers all CE articles to members online at www.kphanet.org

Learning Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: 1.

Recognize the existing barriers to access contraception.

2.

Describe organizational support of pharmacist prescribed hormonal contraception.

3.

Review state legislation authorizing pharmacist-prescribed hormonal contraception.

Pain is one of the most commonly encountered patient complaints among all types of health care practitioners. Approximately 100 million patients in the United States suffer from chronic or acute pain.1 Pain is also a common complication experienced by pregnant women. Pregnancy involves physiological and body changes, including changes in maternal anatomy and hormonal levels. These changes often lead to the onset of painful diseases or exacerbate pre-existing pain.2,3

Headache, musculoskeletal pain, and neuropathic pain (NP) are common types of pain presenting in the pregnant population. This review will focus on the treatment of these three disease states, with migraine type headaches being the main the type of headache addressed.

Migraines are strongly linked to anxiety/mood disorder, allergies, sleep, chronic pain, and epilepsy, which may occur during pregnancy.4 Thus, treatment of headache during pregUntreated or inadequately treated pain can have adverse efnancy is a common patient concern. Musculoskeletal pain fects on the mother and fetus.2 When treating pain in this pop- occurring during pregnancy commonly presents as pain in the ulation, the practitioner should first rule out obstetric causes.3 upper back, lower back, and hips.3 At some point during pregNext, non-pharmacologic treatment such as rest, physiothera- nancy nearly two-thirds of women experience low-back pain py, physical therapy, and even acupuncture should be exand one-fifth experience pelvic pain. This pain can lead to plored. When these methods fail to treat the pain, pharmaco- decreased sleep, interference with daily activities, and missed logic options must be evaluated. When pharmacologic thera- days of work.5 Neuropathic pain is defined as pain caused by py is required, the practitioner should aim to use the smallest a lesion or disease of the somatosensory system. Carpal tundose for the shortest duration. The practitioner must always nel syndrome, sciatica, meralgia, paraesthetica and other weigh the risk to the mother and fetus versus the benefits of nerve entrapment syndromes are types of NP experienced treatment. commonly during pregnancy. Enlargement of the uterus and the development of the fetus cause postural changes and muFew publications exist detailing the pharmacologic treatment tation of the pelvic girdle leading to development of these of non-obstetric pain in pregnant women. This review sumentrapment neuropathies.6 marizes the most common pharmacologic options used in the treatment of common pain syndromes. As stated previously, TREATMENT non-pharmacologic options should be employed first, but As in all conditions during pregnancy, medication use should those are outside the scope of this review. The Food and be minimized in favor of non-pharmacologic interventions Drug Administration (FDA) has recently implemented new 7 pregnancy labeling requirements, which went into effect June when possible. Treatment of acute migraine episodes in non30, 2015. Due to the fact that the previous pregnancy catego- pregnant patients may involve use of non-steroidal antiinflammatories (NSAIDs), acetaminophen, antidepressant ries will be phased out over a period of three years, the old agents, ergot alkaloids, triptans, caffeine, and local therapy, categorization system of A, B, C, D and X was included in such as botulinum toxin. Prophylactic treatment most comthis review. monly involves beta-blockers, anticonvulsants, or antidepresEPIDEMIOLOGY/ETIOLOGY sants.7 |16| Kentucky Pharmacists Association | November/December 2019

when taken around the time of conception.15 Contrary to this, a recent large cohort study did not find increased risk of spontaneous abortions with exposure to NSAIDs.16 As an important exception, significantly increased risk was noted with indomethacin administration. A recent study excluded cases in which NSAIDs were administered on the day before spontaneous abortion took place.17 Given this exclusion, the investigators found no increased risk of abortion, except in the case of indomethacin. These results suggest that NSAIDs were First-line treatment options for NP include pregabalin, being used to treat pain associated with a spontaneous aborgabapentin, tricyclic antidepressants (TCAs), and serotonin tion that had already started or was imminent, and that the and norepinephrine reuptake inhibitors (SNRIs).Other options NSAIDs may not be the direct cause of the abortion.17 Potenfor treatment include topical lidocaine and capsaicin. Opioids tial indication bias is also present in a cohort study that associare generally not recommended for NP pain due to long-term ated NSAID use with quadriparetic cerebral palsy in preterm safety and abuse concerns.9 infants.18 Due to the study design, it is impossible to decide if Many of the available treatment options for pain are associat- NSAIDs were the cause, or if the inflammation being treated ed with increased risk of adverse outcomes when used during by the NSAID caused the damage to the fetal brain. Given the conflicting data, NSAIDs should be used cautiously in pregnancy. This review will focus on acetaminophen, early pregnancy and indomethacin use for pain relief is not NSAIDs, opioids, triptans, TCAs, gabapentin, pregabalin, SNRIs, and topical medications. These medications were se- advisable until further studies clarify its relationship to spontaneous abortion. lected due to the fact that they are first line agents for the treatment of the pain syndromes discussed above, and they NSAID use in the third trimester has been closely linked to may be considered for use in pregnancy. There are several premature closure of the ductus arteriosus.19 Some case reother pharmacologic treatments options available; however, ports have linked late maternal NSAID use to persistent pulthose medications are outside the scope of this review due to monary hypertension in the newborn, but a large, multi-center severe teratogenicity concerns. case-control study found no significant link between the two.20 Musculoskeletal pain is commonly treated with acetaminophen, NSAIDs and opioids. The American Pain Society and American Academy of Pain Medicine have jointly commissioned the development of guidelines for opioid use in chronic non-cancer pain. These guidelines state that chronic opioid therapy should be initiated only when the benefits outweigh the risks in patients with moderate to severe pain that is not relieved by non-opioid therapies.8

Pharmacologic Treatment Options for Pain Acetaminophen

Because of these risks, late-term use of NSAIDs is not recommended.

Opioids

Acetaminophen is classified as pregnancy category B and is recommended as a first line agent for treatment of mild to moderate pain during pregnancy.10 In contrast to opioids, acetaminophen has not been associated with fetal malformations, low birth weights, or other poor delivery outcomes.11

Evidence-based guidelines recommend “minimal or no use� of chronic opioid therapy in pregnancy, however, prescription opioid use is common in women of childbearing age.8 Hydrocodone is the most commonly used opioid in pregnancy, followed by codeine and oxycodone.21 A review of insurance claims found that 27.7% of privately insured and 39.4% of A potential connection between acetaminophen use in pregnancy and risk of asthma in the child has been reported. The Medicaid-enrolled US women aged 15-44 received an opiate 22 mechanism is unknown, but may be linked to the modulating prescription each year from 2008-2012. The overall prevalence of opioid abuse for delivery admissions was estimated at effects of acetaminophen on the pregnant woman’s immune 23 system.12 A meta-analysis found that use in the first trimester 0.39% in 2011, a 127% increase over 0.17% in 1998. The was associated with increased risk of childhood asthma. How- incidence of neonatal abstinence syndrome (NAS) tripled from 2000 to 2009, further indicating an increase in maternal ever, the authors also found high levels of heterogeneity and opiate utilization.24 From 2004 to 2013, the incidence of NAS significant confounders in the analyzed studies. Also, the 13 analysis was based on cohort studies alone. Currently, there in the US increased from 7 cases per 1000 NICU admissions 25 is a lack of randomized controlled trials investigating the link to 27 cases per 1000, a 386% increase. These recent findings are consistent with a trend of increased opioid use and misuse between acetaminophen exposure and asthma. by pregnant mothers.

Acetaminophen exposure during pregnancy has been associatFrom 1992 to 2012 in the United States, the typical mother ed with attention deficit hyperactivity disorder (ADHD)-like reporting opioid abuse was 21-29 years old, non-Hispanic symptoms at age 7 and 11.14 These findings were in the conwhite, unmarried, unemployed, with housing and a high text of observational study designs; other types of trials are 26 needed to establish causation. There is insufficient evidence at school diploma or higher. In the United States, opioid dispensing in pregnancy is highest in the southern states and lowthis time to recommend that pregnant mothers avoid acetaest in the northeast.21 Opioid using mothers may present with minophen for pain management in pregnancy based on purpoor weight gain and signs of IV drug use (needle marks, skin ported connections to asthma and ADHD. infections, HIV or hepatitis C diagnosis). Current practice NSAIDs indicates routine screening by use of validated questionnaires, with urine screenings performed in patients deemed at-risk.27 NSAIDs are available without a prescription and frequently The advent of universal maternal drug testing shows promise used in the general population, including pregnant women. for identifying infants exposed to opiates in mothers that NSAID use has been associated with miscarriage, especially would not be identified by risk-based screening.24 |17| www.KPHANET.org

In chronic users, abrupt opioid withdrawal during pregnancy is not advisable because it can increase the risk of miscarriage or premature delivery.3 Given the noted increased risks to the fetus with maternal opioid abuse, maintenance with an opioid replacement such as methadone or buprenorphine may be warranted. There are no known teratogenic effects when either of these medications are taken as directed and relapse is avoided.28 Methadone use has been associated with low birth weight, a phenomenon not fully attributable to maternal poverty or smoking.29 In a prospective cohort study, the rate of NAS could be reduced by the initiation and tapering of longacting morphine preparations.30 Other neonatal outcomes did not show any clinically significant differences from nonexposed births. Mean birth weight was lower by a statistically significant, but probably not clinically relevant, amount (200g). One study suggests that buprenorphine/naloxone may have lower rates of NAS than methadone when used for maintenance therapy.31 Both medications produce opioid dependence in the newborn which requires assessment and monitoring and may require specific medical care. Readers are referred to recently published federal guidelines discuss the use of methadone and buprenorphine in pregnancy for specific recommendations in the management of these patients.28

Triptans

tives (placebo, no opiate therapy, non-opiate therapy). A relative lack of data on the use of hydrocodone, fentanyl, and oxycodone in pregnancy has been noted.35 Given the risk profile previously noted and a lack of data supporting their superior effectiveness, recent data supports the recommendation that opioids only be used when other options are ineffective.

The Norwegian Mother and Child Cohort Study found no association between first trimester triptan usage and major congenital abnormalities or adverse pregnancy events in their review of 70,000 pregnancies, 1535 of which had triptan exposures. This same study found a small but significant increase in atonic uterus and blood loss during labor for

Triptans are considered first line agents for treatment of acute migraine. Use in pregnancy has been evaluated through postmarketing data collection, prospective trials, and animal data.

In animal studies, sumatriptan demonstrated teratogenicity in rabbits, but not rats.38 These animal studies used doses far exceeding normal human consumption, and their findings have not been followed by evidence of teratogenicity in humans.

The manufacturer of sumatriptan established a registry in 1996 to evaluate the risk of sumatriptan use in pregnancy.

The Sumatriptan Pregnancy Registry was followed by the Naratriptan registry in 2001 and the Treximet Registry in 2008. Analysis of these registries from 1996-2008 revealed 599 sumatriptan exposed pregnancies with known outcomes.

Among these pregnancies, the risk of major birth defects was 4.6% after first trimester and 4.7% after any trimester of sumatriptan exposure. The most common defect found was ventral septal defect (n=4). This rate was less than a 2-fold increase from the major birth defect risk associated with unOpioid use during pregnancy is associated with low birth treated migraneurs and significantly below risks reported for weight ,increased risk of threatened preterm labor, early-onset other known teratogenic agents. No major birth defects were delivery, intrauterine growth retardation, Caesarean delivery, reported among 49 neonates exposed to naratriptan.39 and stillbirth.23,32,33 The absolute risk of developing NAS from In 2001, review of the Swedish Medical Birth Registry rematernal prescription opiate use has been estimated at 5.9 per vealed a lower rate of fetal malformations compared to popu1000; the risk estimate increases to 220.2 per 1000 in cases of lation risk (2.7% vs 3.6%) in deliveries by mothers reporting known opioid misuse. Long-term and late-pregnancy opioid pharmaceutical treatment for migraines during pregnancy. Of use is associated with higher rates of NAS than short-term the 905 women, 658 had been exposed to sumatriptan. There and early-pregnancy use, respectively.34 was no difference in the rate of malformations among those Opiates are also associated with neural tube defects.35 Chilexposed to sumatriptan versus other agents.40 In 2011, evaluadren exposed to methadone in utero were found to have a 5 tion of the same registry revealed an increased risk of pretimes higher risk of failing a clinical vision assessment at 6 eclampsia, caesarean sections and delivery inductions in preg36 months than non-exposed children. A small cohort study nancies exposed to migraine medications; the risk of chronic (n=23 mothers+24 children) also found reduced visual acuity hypertension was also elevated following second and third in drug-exposed children whose mothers underwent detoxifi- trimester exposures. There was no difference in neonatal dication during pregnancy in comparison to non-exposed chil- agnoses following migraine medication exposure compared dren at age 4.5 years.37 Drug exposure in this study was not to non-exposure. A non-significant increase in esophageal limited to opioids. Opioid use during pregnancy also poses atresia was found in 3 infants exposed to sumatriptan in risks to the mother including prolonged hospital stays or utero. No increased risk of congenital malformation was death during hospital stays. Direct inpatient medical cost as- found to result from exposure to migraine treatment during sociated with maternal opiate use was estimated as an averpregnancy. Over 80% of exposures in this study were to a age of $30 million per year from 1998-2009.33 triptan, with sumatriptan accounting for two-thirds of those There have been no recent long-term, randomized controlled exposures. Therefore, caution should be used when extrapolating these findings to medications other than sumatriptan.41 trials of comparing the efficacy of opiate therapy to alterna-

|18| Kentucky Pharmacists Association | November/December 2019

second/third trimester triptan-exposed mothers. Sumatriptan constituted almost half of all exposures. Of note, there were significantly higher exposures to other potentially teratogenic/adverse pregnancy outcome causing medications in the triptan exposed group, which may have confounded these results.42 In 2013, the Norwegian registry was reviewed using prescription data, with no association being found between patients filling prescriptions for triptans during pregnancy and congenital malformations or low birth rate as compared to a comparison group of patients diagnosed with migraines but not filling prescriptions for triptans during pregnancy. There was an increase in postpartum hemorrhage reported with second trimester triptan exposure, which was no different from disease comparison group and therefore possibly attributed to decreased platelet aggregation in severe migraine.43 These results suggest a possible small increase in risk of negative outcomes for migraneurs regardless of triptan use during pregnancy. A 2014 study reported final results from the manufacturer registry. This study reviewed 680 triptan-exposed pregnancies, 626 of which were exposed to sumatriptan, finding a 4.2% estimated risk of major birth defect following first trimester sumatriptan exposure. Low registry enrollment and lack of teratogenicity signals through 16 years of reporting led to the closure of the database.44

monly used TCA in migraine treatment.47,48 However, some case reports and case series describe neonatal withdrawal following exposure to imipramine, amitriptyline and nortriptyline.49-51 Other adverse fetal effects have been noted with amitriptyline exposure in utero. One study found that the risk of preeclampsia was increased in pregnant women treated with TCAs for depression (RR 3.23; 95% CI: 1.87, 5.59), although it was noted that this association may have been due in part to the underlying disease state of depression.52 Another study found an increased risk of spontaneous abortion associated with antidepressant use during pregnancy, however evaluation of TCAs alone did not reach statistical significance, possibly due to small sample size (n=36) (adjusted odds ratio 1.27, 95% CI 0.85 – 1.91).53 A third study found slight increases in risk of miscarriage (relative risk 1.3; 99%CI 1.1-1.5) and pregnancy termination (RR 1.4; 95% CI 1.2-1.7) in women taking TCAs for depression or anxiety compared to unmedicated women with underlying mental illness.54

Contrary to these findings, several studies report no adverse events following fetal exposure to these agents. A case-control study of the Quebec Pregnancy Registry from 1998-2002 found no association between maternal use of TCAs and the risk of infants born SGA.55 In 2002, a study found that gestaAlthough a small risk of birth defects cannot be excluded, tional exposure to TCAs was not associated with any negadata suggest that sumatriptan may be safely used in moderate tive effects on global IQ, language development or behavior doses during pregnancy. at 15 and 71 months of follow up.56 A large 2014 study Little data exists regarding neurodevelopmental effects of in- found no increased risk of cardiac malformation in TCA exutero triptan exposure. A 2016 analysis using the Norwegian posed infants compared to those with no antidepressant expoMother and Child Cohort found a 40% increase in externaliz- sure.57 This is supported by another study which found no ing behaviors, including “attention problems” and increased risk of congenital anomalies pulmonary disease in “aggressive behavior”, among children exposed to triptans in children exposed to TCAs in utero.58 utero, however, absolute risks remained very small at 6%.

Gabapentin Sumatriptan was the most commonly used medication in this Gabapentin is one of the most widely prescribed agents for cohort. Risk was seen primarily in those exposed during the the treatment of NP and it is recommended as a first-line first trimester. Many confounders exist, including heritable treatment option.9 Gabapentin is classified as pregnancy caterisks of externalizing behaviors, higher rates of other neurologic medication use, probabilistic bias, and loss of follow up gory C, with no adequate and well-controlled studies in pregamong the participants. Cautious interpretation of this study nancy. Manufacturers currently recommend the use of this is suggested, and practice should not be changed without rep- medication during pregnancy only if the potential benefit justifies the potential risk to the fetus.59 lication of results in future studies. Sufficient data regarding triptans other than sumatriptan is lacking with regard to birth or neurocognitive defects.45

Although adequate studies are not available in humans, gabapentin use in animals has been studied. These studies have demonstrated developmental toxicity in pregnant mice, TCAs rats, and rabbits at doses similar to or lower than those used TCAs may be used first line for migraine prophylaxis and the clinically.59 Increased incidence of hydroureter and/or hytreatment of NP. Withdrawal symptoms, such as poor feeddronephrosis occurred in rat studies, as well as delayed ossifiing, tachypnea, muscle tone changes, impaired thermoregulacation of bones in the skull, vertebrae, and hind limbs. An tion, irritability, and seizures may occur in infants following increase in fetal mortality occurred at doses approximately maternal use of tricyclic antidepressants.46 Most reports of this one-fourth to eight times the recommended maximum human phenomenon are following use of clomipramine, a less com|19| www.KPHANET.org

dose.59,60

Pregabalin

Most gabapentin data comes from use in patients with seizure disorders and is complicated by the fact that gabapentin is used as combination therapy in many of these patients. The Gabapentin Pregnancy Registry collected data from 39 women, resulting in 51 fetuses, who received gabapentin during pregnancy. The vast majority of these women were receiving gabapentin for epilepsy, with two receiving it for pain and one for bipolar disorder. Of the 51 fetuses, 44 were live births, with six miscarriages and one elective abortion. Of these 44 births there were two major malformations and one minor, and these occurred in patients receiving treatment with multiple agents. No malformations were seen in babies born to 11 women who received gabapentin monotherapy for the entirety of the pregnancy. The authors conclude that the rate of major congenital malformations in this sample (4.5%) is higher than the rate in the general population (2-4%), but is consistent with the rate in infants of epileptic mothers (4-8%).

Pregabalin is structurally related to gabapentin, but it is not active at GABA receptors. Like gabapentin it is a pregnancy category C. There are no adequate and well controlled studies in pregnancy women, and the manufacturer recommends use during pregnancy only if the potential benefit justifies the potential risk to the fetus.64 Although data exists on the use of this medication in pregnant animals, there is minimal evidence available for use in humans.

Animal studies have shown risks of major malformations, growth retardation, and advanced ossification with the administration of pregabalin. Studies on the fetuses of rabbits demonstrated decreased fetal body weight, and increased skeletal malformations, visceral variations, and retarded ossification. Similar results were observed in pregnant rats receiving the medication throughout the period of organogenesis including skull alterations, skeletal variations, and retarded ossification.64

They also state that the rate of minor malformations (2.2%) falls below the rate for the general population (3-10%) and infants of epileptic mothers (6-20%).60

No studies solely evaluating pregabalinâ&#x20AC;&#x2122;s use in pregnancy were found. A 2014 study reviewed the medical birth registry of Norway from 1999-2011 totaling 2,600 deliveries by mothers exposed to antiepileptic drugs. Outcomes from those delivA more recent prospective study compared 223 pregnancies eries were compared to 3,773 children born to mothers with exposed to gabapentin with 223 pregnancies not exposed to epilepsy receiving no treatment. Of those 30 patients were any known teratogens. There were 7 major malformations in receiving pregabalin. Exposure to pregabalin monotherapy was not associated with an increased rate of malformations. the gabapentin group and 5 in the non-teratogen group (p= The authors noted a limitation in the small size of some of the 0.555), yielding no statistical difference. Of note, no malforexposed groups possibly underpowering the study to detect mation occurred in the 36 women receiving gabapentin mono- risks of specific birth defects for each medications.65 therapy. There were also no differences in the groups in reSNRIs gards to spontaneous abortions (22 vs. 17; p= 0.502), still births (2 vs. 0), or intrauterine growth retardation (6 vs. 4; p= Duloxetine and venlafaxine are SNRIs recommended by evidence-based guidelines for the treatment of NP as well as the 0.422). There was a significantly higher rate of preterm birth treatment and/or prevention of migraine headaches.9 Both in the gabapentin group (18 vs. 8; p=0.019) as well as low medications are classified as pregnancy category C, and manbirth weight (18 vs. 9; p=0.033). Also the number of lives ufacturers recommend use in pregnancy only if the potential births was lower in the gabapentin group (170 vs. 223; p< benefit justifies the potential risk to the fetus.66,67 No ade0.001). Also of note, 23 of 61 infants exposed to gabapentin up until delivery required admission to the neonatal intensive quate and well-controlled studies have been conducted in care unit vs. 6 in the nonteratogen group (p <0.001). The au- pregnant women. thors conclude that although the sample size is too small to Duloxetine animal studies in rats and rabbits found evidence make a definitive conclusion, gabapentin does not appear to of a decrease in fetal weights but no increase in teratogenicity increase the rate of major malformations.61 at doses four to seven times the maximum recommended human dose. When administered to pregnant rats through gestaA much larger prospective population-based cohort study tion and lactation the survival of pups to 1 day postpartum evaluated 837,795 live births in Denmark from 1996 to 2008 and pup body weights at birth were decreased at a dose of two to study all newer-generation antiepileptic medications times the maximum recommended human dose. At this dose (lamotrigine, oxcarbazepine, topiramate, gabapentin, levetiracetam). Of this large cohort only 59 women were receiv- the rat pup exhibited behaviors consistent with increased reacing gabapentin during the first trimester, resulting in one ma- tivity.66 Venlafaxine findings are similar, with no malformations observed in rats or rabbits at doses 2.5 to 4 times the jor birth defect.62 Finally, a 2010 study evaluated the use of gabapentin for the treatment of hyperemesis gravidarum. Only maximum recommended human dose. Rat studies did find a 7 women were enrolled and doses ranged from 900 mg/day to decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first five days of lactation at 3600 mg/day (mean dose 1843 mg/day). Of the 7 women enrolled there were two major birth defects, a tethered spinal dose 2.5 times the maximum recommended human dose.67 cord and hydronephrosis.63 A 2013 study evaluated pregnancy outcome data from the |20| Kentucky Pharmacists Association | November/December 2019

Lilly Safety System (LSS), which collects data involving adverse events associated with Lilly products, and the FDA Adverse Events Reporting System. Data was reviewed from 2004 through 2011. The majority (74%) of patients were receiving duloxetine for depression. The LSS database identified 400 pregnancies with known outcomes and the FDA system reported 176. Ninety cases of abnormal pregnancy outcome were found in the LSS database consisting of spontaneous abortions (n=41), post/perinatal conditions (n= 25) or premature births (n= 19). The authors conclude that the data analyzed from both sources suggest that the frequency of abnormal outcomes reported is generally consistent with the historic control rates in the general population.68 A 2015 literature review of the use in SNRIs in pregnancy found that limited data on the use of duloxetine exists. However, the data reviewed did suggest that major malformations were within the rate of the general population, but spontaneous abortion rates were actually increased.69 Compared to duloxetine, more human data exists on the use of venlafaxine in pregnancy. One report studied 150 women exposed to venlafaxine during pregnancy compared to 150 women receiving serotonin reuptake inhibitors (SSRIs) and 150 women receiving non-teratogenic drugs. Results showed no increase in major malformations above the baseline rate of 1-3%.70 A 2007 retrospective review using the Swedish Medical Birth Registry collected data on 732 pregnant women exposed to SNRI/NRI medications. Seventy percent of these women were receiving venlafaxine (501 receiving monotherapy and 12 receiving combination therapy with either mirtazapine, mianserin or reboxetine). The rate of preterm births was significantly increased ( odds ratio, 1.6; 95% CI 1.19-2.15), with neonatal symptoms such as respiratory problems, low Apgar score, hypoglycemia, and convulsions showing similar results as infants exposed to SSRIs. Although congenital malformations did occur, there was no increased risk in the women exposed to these medications.71 A 2007 literature review of 15 studies found that exposure to venlafaxine as well as other antidepressants was not associated with an increased risk of major congenital malformations. 72 A more recent 2015 multi-country population based cohort study reviewed 36,772 infants exposed to SSRIs (2,763 exposed to venlafaxine). The investigators used a sibling controlled analysis, restricting the study population to women with at least two children in the database. Results using this sibling control showed no substantial increase in overall cardiac birth defects, however; the prevalence of septal defects and right ventricular outflow tract defects was higher. The investigators concluded that the findings do not illustrate a substantial teratogenic effect of SSRIs or venlafaxine.73 Despite the above data not finding a link between venlafaxine and teratogenicity, conflicting data exists. Using data from the National Birth Defects

Prevention Study (NBDPS), investigators analyzed outcomes in mothers taking venlafaxine with children born with selected birth defects compared to controls of babies born without birth defects. Only 14 of 8,002 control mothers and 77 out of 19,043 case mothers reported use of venlafaxine from one month preconception through the third month of pregnancy.

Contrary to results in the previous study, statistically significant malformations were observed.74 The clinician must also consider the immediate effects of these medication on the newborn infant. Use of SNRIs has led to the development of complications requiring prolonged hospitalization, respiratory support and tube feeding in neonates.

Complications have included respiratory distress, cyanosis, apnea, seizures, temperature instabilities, feeding difficulties, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These complications are caused by either a direct toxic effect to the neonate, or a drug discontinuation syndrome.66,67 A retrospective cohort study compared 76 mothers taking SSRIs or venlafaxine during the third trimester with 90 untreated mothers.

Infants in the study group exhibited behavioral signs of the central nervous system and respiratory system. Compared with term infants, all premature infants exhibited behavioral manifestations, requiring up to a four time longer stay in the hospital.75 Poor Neonatal Adaptation (PNA) occurs in neonates exposed to psychotropic drugs in utero. The risk of PNA in infants exposed to SSRIs in utero is between 20%-70%, and the risk after exposure to venlafaxine appears to be comparable to that risk.76 Topical Treatment Topical lidocaine and capsaicin are acceptable treatment options for both musculoskeletal pain and NP. The topical lidocaine patch is classified as pregnancy category B. When used according to the manufacturerâ&#x20AC;&#x2122;s dosing recommendations, only 3 Âą 2% of the dose applied is absorbed. The mean peak blood concentration of the lidocaine patch is approximately 1/10 of the therapeutic concentration used to treat cardiac arrhythmias.77 No studies are currently available on the use of this medication in pregnant women.

Capsaicin is available in numerous topical formulations including creams, gels, topical liquid, lotions, and patches. The 8% patch is classified as pregnancy category B. No evidence of fetal teratogenicity was found in rats with use of doses significantly higher than those used clinically.78 Currently there are no studies evaluating the use of capsaicin in pregnancy women. Due to the small amounts absorbed via the transdermal route, it is unlikely to cause an adverse effect in humans.79 CONCLUSION |21| www.KPHANET.org

Data regarding pain management in pregnancy is minimal, and often extrapolated from studies in other disease states.

This may confound interpretation of results, as the underlying conditions may affect risk of adverse fetal effects. Clinicians involved in treating pain during pregnancy should strive to balance risks of maternal discomfort with those of fetal exposure to medications. When possible, non-pharmacologic options should be employed first and used at the lowest doses for the shortest duration that will adequately manage the pain.

Post-marketing surveillance remains an important avenue for continued research in this area. Clinicians should enroll patients in registries, when available, and report outcomes regarding use of pain management agents in pregnant populations.

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Whiteman VE, Salemi JL, Mogos MF, Cain MA, Aliyu MH, Salihu HM. Maternal opioid drug use during pregnancy and its impact on perinatal morbidity, mortality, and the costs of medical care in the United States. J pregnancy. 2014:906723,

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Desai RJ, Huybrechts KF, Hernandez-Diaz S, et al. Exposure to prescription opioid analgesics in utero and risk of neonatal abstinence syndrome: population based cohort study. BMJ. 2015;350:h2102.

35.

Pritham UA, McKay L. Safe management of chronic pain in pregnancy in an era of opioid misuse and abuse. J Obstet Gynecol Neonatal Nurs. 2014;43(5):554-567.

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Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and Education: Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education and Research. The National Academies Press, 2011. http://books.nap.edu/ openbook.php?record_id=13172&page=1.

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Lalkhen A. Grady K. Non-obstetric pain in pregnancy. British Journal of Pain.2008;1(2):10 -14.

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Díaz RR, Rivera AL. Management of non-obstetric pain during pregnancy. Review article.

Colombian Journal of Anesthesiology. 2012;40(3):213-223.

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IASP. Global year against Headache. Epidemiology of headache. Available at: http:// www.iasp-pain.org/files/Content/ContentFolders/GlobalYearAgainstPain2/ HeadacheFactSheets/1-Epidemiology.pdf. Accessed 6/26/15.

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Pennick V, Liddle SD. Interventions for preventing and treating pelvic and back pain in pregnancy. Cochrane Database Syst Rev. 2013;8:CD001139.

6.

Costantino M, Guaraldi C, Costantino D, De Grazia S, Unfer V. Peripheral neuropathy in obstetrics: efficacy and safety of α-lipoic acid supplementation. Eur Rev Med Pharmacol Sci. 2014;18(18):2766-2771.

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Dodick D, Dilli E. Information for Health Care Professionals: Chronic Daily Headache. The American Headache Society. Available at: http://www.americanheadachesociety.org/ assets/1/7/David_Dodick_and_Esma_Dilli_-_Chronic_Daily_Headache.pdf. Accessed 6/25/15.

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Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-130

9.

.Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-173.

10.

MacGregor EA. Migraine in pregnancy and lactation. Neurol Sci. 2014;35(1):S61-S64.

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Scialli AR, Ang R, Breitmeyer J, Royal MA. A review of the literature on the effects of acetaminophen on pregnancy outcome .Reprod Toxicol.2010;30(4):495-507.

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Thiele K, Kessler T, Arck P, Erhardt A, Tiegs G. Acetaminophen and pregnancy: short-and long-term consequences for mother and child. J Reprod Immunol. 2013;97(1):128-139.

13.

Cheelo M, Lodge C, Dharmage S, et al. Paracetamol exposure in pregnancy and early childhood and development of childhood asthma: a systematic review and meta-analysis.

Arch Dis Child. 2015;100(1):81-89.

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Thompson JM, Waldie KE, Wall CR, Murphy R, Mitchell EA, Group AS. Associations between acetaminophen use during pregnancy and ADHD symptoms measured at ages 7 and 11 years. PLoS One. 2014;9(9):e108210.

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McGlone L, Hamilton R, McCulloch DL, MacKinnon JR, Bradnam M, Mactier H. Visual outcome in infants born to drug-misusing mothers prescribed methadone in pregnancy. Br J Ophthalmol. 2014;98(2):238-245.

15.

Nakhai-Pour HR, Broy P, Sheehy O, Bérard A. Use of nonaspirin nonsteroidal antiinflammatory drugs during pregnancy and the risk of spontaneous abortion. CMAJ. 2011;183(15):1713-1720.

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Walhovd KB, Bjørnebekk A, Haabrekke K, et al. Child Neuroanatomical, Neurocognitive, and Visual Acuity Outcomes With Maternal Opioid and Polysubstance Detoxification.

Pediatr Neurol. 2015;52(3):326-332.e323.

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Daniel S, Koren G, Lunenfeld E, Bilenko N, Ratzon R, Levy A. Fetal exposure to nonsteroidal anti-inflammatory drugs and spontaneous abortions. CMAJ. 2014;186(5):E177-E182.

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Ezoki H, Utusumi M, Tokado H. Reproductive study on sumatriptan succinate in rats by oral route. Yakuri Chiryo. 1993;21:2071-2091.

17.

Daniel S, Koren G, Lunenfeld E, Levy A. NSAIDs and spontaneous abortions–true effect or

39.

Cunnington M, Ephross S, Churchill P. The safety of sumatriptan and naratriptan in

|22| Kentucky Pharmacists Association | November/December 2019

pregnancy: what have we learned? Headache.2009;49:1414-1422.

65.

Kallen B. Lygner PE. Delivery outcome in women who used drugs for migraine during pregnancy with special reference to sumatriptan. Headache. 2001;41:351-356.

Veiby G, Daltveit AK, Engelsen BA, Gilhus NE. Fetal growth restriction and birth defects with newer and older antiepileptic drugs during pregnancy. J Neurol. 2014;261(3):579-588.

66.

41.

Kallen B. Nilsson E, Olausson PO. Delivery Outcome after maternal use of drugs for migraine: a register study in Sweden. Drug Saf. 2011;34(8):691-703.

Cymbalta [package insert]. Lilly USA, LLC. Indianapolis, IN. December 2014. http:// pi.lilly.com/us/cymbalta-pi.pdf. Accessed June 18, 2015.

67.

42.

Nezvalova-Henriksen K, Spigset O, Nordeng H. Triptan exposure during pregnancy and the risk of major congenital malformations and adverse pregnancy outcomes: results from the Norwegian Mother and Child Cohort Study. Headache. 2010;50(4):563-575.

Effexor [package insert]. Wyeth Pharmaceuticals Inc., Philadelphia, PA. February 2015. http://labeling.pfizer.com/showlabeling.aspx?ID=100. Accessed June 18, 2015.

68.

Hoog SL, Cheng Y, Elpers J, Dowsett SA. Duloxetine and pregnancy outcomes: safety surveillance findings. Int J Med Sci. 2013;10(4):413-419.

69.

Bellantuono C, Vargas M, Mandarelli G, Nardi B, Martini MG. The safety of serotoninnoradrenaline reuptake inhibitors (SNRIs) in pregnancy and breastfeeding: a comprehensive review. Hum Psychopharmacol. 2015;30(3):143-151.

40.

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Nezvalova Henriksen K, Spigset O, Nordent H. Triptan safety during pregnancy: a Norwegian population registry study. Eur J Epidemiol. 2013;28:759-769.

44.

Ephross SA, Sinclair SM. Final Results from the 16-year sumatriptan, naratriptan, and treximet pregnancy registry. Headache. 2014;54:1158-1172.

70.

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Wood ME, Lapane K, Frazier JA, et. al. Prenatal Triptan Exposure and Internalising and Externalising Behavior Problems in 3-year-old Children: Results from the Norwegian Mother and Child Cohort Study. Paed Peri Epidemiol. 2016;30:190-200.

Einarson A, Fatoye B, Sarkar M. Pregnancy outcome following gestational exposure to venlafaxine: a multicenter prospective controlled study. Am J Psychiatry. 2001;158(10):17281730.

71.

46.

Gentile S. On categorizing gestational, birth, and neonatal complications following late pregnancy exposure to antidepressants: the prenatal antidepressant exposure syndrome. CNS Spectr. 2010;15(3):167-185.

Lennestål R, Källén B. Delivery outcome in relation to maternal use of some recently introduced antidepressants. J Clin Psychopharmacol. 2007;27(6):607-613.

72.

Bellantuono C1, Migliarese G, Gentile S. Serotonin reuptake inhibitors in pregnancy and the risk of major malformations: a systematic review. Hum Psychopharmacol. 2007;22 (3):121-128.

73.

Furu K, Kieler H, Haglund B, et al. Selective serotonin reuptake inhibitors and venlafaxine in early pregnancy and risk of birth defects: population based cohort study and sibling design.

BMJ. 2015;350:h1798.

74.

Polen KN, Rasmussen SA, Riehle-Colarusso T, et al. Association between reported venlafaxine use in early pregnancy and birth defects, national birth defects prevention study, 19972007. Birth Defects Res A Clin Mol Teratol.2013;97:28-35.

75.

Ferreira E, Carceller AM, Agogué C. Effects of selective serotonin reuptake inhibitors and venlafaxine during pregnancy in term and preterm neonates. Pediatrics. 2007;119(1):52-59.

76.

Kieviet N, Dolman KM, Honig A. The use of psychotropic medication during pregnancy: how about the newborn? Neuropsychiatr Dis Treat. 2013;9:1257-1266.

77.

Lidoderm [package insert]. Endo Pharmaceuticals Inc., Malvern, PA. January 2015. http://www.endo.com/File%20Library/Products/Prescribing%20Information/ LIDODERM_prescribing_information.html. Accessed June 20th, 2015.

78.

Qutenza [package insert]. Acorda Therapeutics Inc., Ardsley, NY. http:// www.qutenza.com/_docs/qutenza_full_PI_.pdf. Accessed June 20th, 2015.

79.

Lalkhen A. Grady K. Non-obstetric pain in pregnancy. British Journal of Pain.2008;1(2):10 -14.

47.

Bloem BB, Lammers GJ, Roofhooft DWE, De Beaufort AJ, Brouwer OR Clorimipramine withdrawal in newboms [Letter]. Arch Dis Chiid Fetal Neonatal Ed. 1999:81 :R77-R79.

48.

Bromiker R, Kaplan M. Apparent intrauterine fetal withdrawal from clorimipramine hydrochloride [Letter]. JAMA, 1994;272:1722-1723.

49.

Shearer WT, Schreiner RL, Marshall RE. urinary retention in a neonate secondary to maternal ingestion of nortriptyline. J Pediatr. 1972;81:570-572.

50.

Eggermont E, Raveschot J, Deneve V, Casteels-Van Daele M. The adverse influence of imipramine on the adaptation of the newborn infant to extrauterine life. Acta Paediatr.

1972;26:197-204.

51.

Webster PA. Withdrawal symptoms in neonates associated with maternal antidepressant therapy. Lancet. 1973;8:318-319.

52.

Palmsten K, Setoguchi S, Margulis AV, Patrick AR, Hernandez-Diaz S. Elevated risk of preeclampsia in pregnant women with depression: depression or antidepressants. Am J Epidemiol. 2012;175(10):988-997

53.

Nakhai-Pour HR, Broy P, Berard A. Use of antidepressants during pregnancy and the risk of spontaneous abortion. CMAJ. 2010;182(10):1031-1037.

54.

Ban L, Tata LJ, West J, Fiaschi L, Gibson JE. Live and non-live pregnancy outcomes among women with depression and anxiety: a population based-study. PLoS ONE. 2012;7 (8): e43462 doi: 10.1371/journal.pone.0043462.

55.

Ramos E, St-Andre M, Berard A. Association between antidepressant use during pregnancy and infants born small for gestational age. Can J Psych. 2010;55(10):643-652.

56.

Nulman I, Rovet J, Stewart DE, Wolpin J, Pace-Asciak P, Shuhaiber S, Koren G. Child development following exposure to tricyclic antidepressants or fluoxetine throughout fetal life: a prospective controlled study. Am J Psychiatry. 2002;159:1889-1895.

57.

Huybrechts KF, Palmsten K, Avorn J, Cohen LS, Holmes LB, Franklin JM, Mogun H, Levin R, Kowal M, Setofuchi S, Hernandez-Diaz S. Antidepressant use in pregnancy and the risk of cardiac defects. N Engl J Med. 2014;370:2397-2407.

58.

Vasilakis-Scaramozza C, Aschengrau A, Cabral H, Jick SS. Antidepressant use during early pregnancy and the risk of congenital anomalies. Pharmacotherapy. 2013;33(7):693-700.

59.

Neurontin [package insert]. Parke-Davis Division of Pfizer, Inc., New York, NY. April 2015. http://labeling.pfizer.com/ShowLabeling.aspx?id=630. Accessed June 12, 2015.

60.

Montouris G. Gabapentin exposure in human pregnancy: results from the Gabapentin Pregnancy Registry. Epilepsy Behav. 2003;4(3):310-317.

61.

Fujii H, Goel A, Bernard N. Pregnancy outcomes following gabapentin use: results of a prospective comparative cohort study. Neurology. 2013;80(17):1565-1570.

62.

Mølgaard-Nielsen D, Hviid A. Newer-generation antiepileptic drugs and the risk of major birth defects. JAMA. 2011;305(19):1996-2002.

63.

Guttuso T Jr, Robinson LK, Amankwah KS. Gabapentin use in hyperemesis gravidarum: a pilot study. Early Hum Dev. 2010;86(1):65-66.

64.

Lyrica [package insert]. Parke-Davis Division of Pfizer, Inc.; New York, NY. December 2013. http://labeling.pfizer.com/ShowLabeling.aspx?id=561. Accessed June 18, 2015.

|23| www.KPHANET.org

December 2019 â&#x20AC;&#x201D; Pain Management in the Pregnant Patient: A Review 1. Pain in pregnancy may be attributable to what cause?

A. Exacerbation of pre-existing pain conditions B. Underlying physiological changes C. New onset conditions D. All of the above may cause pain during pregnancy 2. What is the first step to take when treating pain in a pregnant patient?

A. Rule out obstetric causes B. Minimize weight-bearing activities C. Initiate non-prescription therapy D. Admit the patient for observation 3. Which principles should guide treatment of pain in during pregnancy?

A. Use maximum doses to quickly eradicate pain B. Use the smallest dose for the shortest duration C. Consider risk to the mother over risk to fetus D. Avoid pharmacologic treatment in ambulatory patients 4. Which are the three most common types of pain presenting during pregnancy?

A. Headache, stomach pain, joint pain B. Psychosomatic pain, musculoskeletal pain, neuropathic pain C. Headache, musculoskeletal pain, neuropathic pain D. Psychosomatic pain, stomach pain, joint pain 5. Which is the first line agent for mild-moderate pain during pregnancy?

7. Opioid use during pregnancy may present with which of the following?

A. Excess weight gain B. Hepatitis C C. Melasma D. Asthma 8. Abrupt opioid withdrawal during pregnancy may lead to which outcome?

A. Miscarriage B. Low birth weight C. Birth defects D. Tobacco use 9. Use of which agent (s) during pregnancy is associated with neural tube defects?

A. NSAIDS B. Opioids C. TCAs D. SSRIs 10. How does the rate of major birth defects among triptan users compare to that in untreated migraneurs during pregnancy?

A. 2-fold decrease among triptan users B. Equivalent risk among both groups C. 2-fold increase among triptan users D. 5-fold increase among triptan users

A. Acetaminophen B. Ibuprofen C. Naproxen D. Sertraline 6. The risk of premature closure of the ductus arteriosus with NSAIDs is most concerning during which trimester?

A. First B. Second C. Third D. The risk is equivalent throughout pregnancy |24| Kentucky Pharmacists Association | November/December 2019

This activity is a FREE service to members of the Kentucky Pharmacists Association.

The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

Expiration Date: 11/21/22 Successful Completion: Score of 80% will result in 2.5 contact hours TECHNICIANS ANSWER SHEET. December 2019 â&#x20AC;&#x201D; Pain Management in the Pregnant Patient: A Review 2.5 contact hours) Universal Activity #0143-0000-19-012-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

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Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

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PHARMACISTS ANSWER SHEET December 2019 â&#x20AC;&#x201D; Pain Management in the Pregnant Patient: A Review (2.5 contact hours) Universal Activity #0143-0000-19-012-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________

PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

3. A B C D 4. A B C D

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Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

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The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education. |25| www.KPHANET.org

Pharmacy Policy Issues Neonatal Abstinence Syndrome Author: Sarah N. Langford is a third professional year student in the PharmD degree program at the University of Kentucky College of Pharmacy. A native of Ann Arbor, MI, she completed her pre-professional studies at UK with a major in Medical Laboratory Sciences.

Issue: I’ve been hearing more and more about Neonatal Abstinence Syndrome about babies in Kentucky. What is this disorder? Is it really that much of a concern in this state? What are some contemporary approaches to handling these delicate patients?

Discussion: Neonatal abstinence syndrome (NAS) is a postnatal opioid withdrawal syndrome affecting increasing numbers of newborns throughout the country, especially in Kentucky. According to the U.S. Department of Health and Human Services (DHHS), NAS incidence has increased nationally from around 3 births per 1,000 to nearly 6 between 2009 and 2012. In the East South Central Division (which contains Kentucky), this rate has risen to over 16 births per 1,000.

These increases are thought to be a result of overprescribing opioid pain relievers; Kentucky is one of the top 5 prescribing states of short-acting opioids. This preventable syndrome has both significant financial cost and a detrimental impact on the neonate’s quality of early life. This disorder causes constant agitation and requires longer hospital stays due to complications such as neonatal respiratory and feeding difficulty, seizures, and low birthweight. DHHS has also reported that the hospital cost for pharmacologically treated NAS infants is approximately $90,000 more than that of uncomplicated term infants, and that these NAS infants are 35% more likely to be ensured by state Medicaid programs.

Accepted non-pharmacological treatments include decreasing stimuli with dimmed lights and lower noise, swaddling the infant tightly with its arms down, curling the infant into a “C position” with their knees and chin toward the chest, bathing the infant in warm water, slow vertical rocking, and horizontal swaying. By combining pharmacological and non-pharmacological treatments, hospitals are able to alleviate some of the hypersensitivity, gastrointestinal issues, agitation, and uncomfortable muscle sensations that may come with opioid withdrawal.

On the legislative side, Kentucky recently enacted a law to make it easier to remove NAS infants from their mothers. This law has expanded the definition of child abuse to include prenatal opioid exposure that causes NAS. If it is determined that an infant is suffering child abuse from NAS, parental rights will be terminated unless the mother enrolls in an addiction treatment program within 90 days. Critics of this new law claim that these legal penalties could dissuade women from seeking necessary prenatal care. Others claim that the law is not strict enough; mothers can keep their child after they complete the required rehabilitation program and go back to using drugs before their next pregnancy with no additional penalties.

To help combat this problem and try to prevent the termination of parental rights, facilities such as Karen’s In the clinical setting, this syndrome is handled by both Place Maternity Center in Louisa, KY, have opened their doors to drug-addicted pregnant women. This 16pharmacological and non-pharmacological methods.

The University of Kentucky Children’s Hospital in Lex- bed rehabilitation facility allows the women to live ington begins treating the infants with either buprenor- there toward the end of their pregnancy and return for phine (if the mother was taking buprenorphine) or mor- up to 90 days after their delivery. Between these maternal care facilities, the state’s new law regarding the defiphine sulfate (if the mother was taking any other opinition of child abuse, and increasing restrictions on opioid) when their Finnegan scores are determined to reoid prescribing, there is hope to see a decrease in the quire treatment based on their adopted protocol. Deincidence of NAS in future years. pending on the progression of the neonate’s Finnegan score, medications such as clonidine, phenobarbital, or valium can be added, or the weaning process can begin.

Continued on p. 27 |26| Kentucky Pharmacists Association | November/December 2019

Campus Corner UK College of Pharmacy Participates in Drug Take Back Day Author: Mallory Olson, University of Kentucky College of Pharmacy

Students in UK’s College of Pharmacy joined forces with members of the Lexington Police Department to collect unused, unwanted or expired prescription medication.



Thermometers



Aerosol cans



Hydrogen peroxide

In all, the group collected nearly 1,800 pounds of medication from city residents during Drug Take Back Day, a bi-annual event that helps prevent drug addiction and overdose deaths.



Illegal drugs

The Drug Enforcement Administration (DEA) says a 2018 national survey showed 9.9 million Americans misused controlled prescription drugs. A majority of abused prescription drugs came from medicine cabinets of family and friends.

Note: You can place used needles inside a coffee can, seal it and then dispose of the can in your household trash.

Pharmacy Policy Issues Continued from p. 26 Resources: 

“We are at crisis level in the state of Kentucky when it comes to  substance use disorder and overdose incidents,” said Trish Freeman, director of the Center for the Advancement of Pharmacy Practice. “Excess supply of unused and unneeded  medications should be disposed of so that they do not end up in the hands of someone they could harm.”

Another Drug Take Back Day will be scheduled for Lexington in the spring. In the meantime, check with your local pharmacy about dropping off unused prescription drugs. Otherwise, you can drop off any qualified medication Monday through Friday during normal business hours at the Fayette County Sheriff’s Office at 150 N. Limestone, Ste. 236, or at the Lexington Police Headquarters at 150 E. Main.



http://www.wkyt.com/content/news/New415505503.html http://www.kentucky.com/news/politics-government/ article210402579.html Patrick SW, Davis MM, Lehmann CU, Cooper WO. Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012. J Perinatology, 2015 August;35(8): 50-655, doi:10.1038/ jp.2015.36 Kentucky Children’s Hospital Clinical Practice Guidelines, Lexington, KY Non-pharmacological Interventions for Infant with Drug Withdrawal Buprenorphine Weaning Protocol NAS Treatment Algorithm 2.0

Have an Idea?: This column is designed to address timely and practical issues of interest to pharmacists, pharmacy inAll of the items accepted are destroyed in an incinerator. terns and pharmacy technicians with the goal being to encourage thought, reflection and exchange among practitioners.

Here is a list of what types of medication are accepted: Suggestions regarding topics for consideration are welcome.  Prescription and over the counter (OTC) pills Please send them to jfink@uky.edu. 

Vitamins



Medicated ointments and lotions



Pet medicine



Some liquids

These items are restricted: 

Needles



Inhalers |27| www.KPHANET.org

|28| Kentucky Pharmacists Association | November/December 2019

Welcome to KPhA! Weâ&#x20AC;&#x2122;re so happy to have you!

The list reflects new memberships received from September 1, 2019â&#x20AC;&#x201D; October 31, 2019 Brittany Antle, Jamestown

Laura Larcara, Louisville

Wesley Rowe, Pikeville

Stephen Bessler, Covington

Sara Lee, Dunmor

Kelley Singer, Elizabethtown

Jimmy Buchanan, Lexington

Elizabeth Magner, Lexington

Randy Stiles, Pikeville

Cody Davis, Paducah

Karen Maples, Danville

David Triplett, Louisville

Katherine Deegan, Fort Thomas

Tara Olash, Louisville

Nelda Eads, Campbellsville

Lavanya Peter, Louisville

Justin Fiske, Shepherdsville

Lance Piecoro, Lexington

Jonathan Grider, Russell Springs

Michael Redel, Elkton

Geoffrey Groenke, Lexington

Harold Ross, West Terre Haute

|29| www.KPHANET.org

Pharmacy Law Brief Various Issues with Power of Attorney Documents Author: Joseph L. Fink III, BSPharm., JD, DSc (Hon), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy Question: From time to time I hear people speaking about power of attorney documents. Sometimes it’s in the context of health care decision-making and other times I hear it referred to in the general realm of business transactions. Can you explain the role of those documents?

Response: Your question presents the important perspective that for pharmacists a power of attorney document may have applicability in one’s personal life or in his or her professional affairs. Pharmacists may encounter these legal documents in either facet of their lives.

Our focus for this discussion will be on the personal life of the person involved. A discussion that is more extensive and complete can be found elsewhere.1

Disclaimer: The information in this column is intended for educational use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of professional practice. It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render advice in accordance with the full information.

dent or perhaps from the progression of a form of dementia. Could such a turn of events negate the conferral of authority? It may at least open the door for casting doubt on the validity and current authority of the conferral. Based on that possibility, today one sees preparation of power-of-attorney documents that are designatA power of attorney document is written authority to act conferred on another by the principal or grantor. It ed Durable Power-of-Attorney. The word “durable” in authorizes someone else to “stand in” for you and exer- the title means that the conferral of authority to act survives the mental incapacity of the principal. cise all the legal authority you would have yourself as outlined in the document. The recipient of this grant of A Uniform Power of Attorney Act was drafted by the authority is referred to as the agent or attorney-in-fact. National Conference of Commissioners on Uniform It is important to differentiate an attorney-in-fact from State Laws during 2006 in an attempt to bring some an attorney-at-law; the latter is a designation used for uniformity across jurisdictions to the law in this area. one licensed and authorized to engage in the practice of As with many other initiatives from that highly respectlaw and represent or advocate for another individual or ed source, there was rapid and extensive adoption of entity. To serve as an attorney-in-fact requires no such the model statute with all states except Louisiana licensure. adopting it within five years.

The individual conferring authority on another may make that grant broad or narrow, i.e., to conduct any and all affairs on behalf of the principal or to act only with regard to certain types of decisions. An example of this latter type would be a health care power of attorney, authorizing someone else to make health care decisions for the care of the principal when he or she is unable to do so.

As with all legal affairs, it would be the best recommendation that if one is thinking about executing a power of attorney to confer authority on another that this be done following consultation with an experienced attorney-at-law who can raise potential issues with you and explore options to help be certain that the goal of this action is achieved. Preparation of such documents is typically not very expensive and the peace of mind one gets from having it done by a professional experienced While thinking of this in the area of health care deciin the field can be well worth it. Is it wise to place relision-making, it is important to discuss the possibility that the principal who is conferring authority on anoth- ance for such an important document on something retrieved from the Internet? Probably not. er may have some turn of events that has a major adverse impact on that person’s mental capacity. It could Reference: 1. Fink III JL. Power of attorney documents and pharmacy.

Hosp Pharm. 2006(July);41:664-668. be due to a severe brain injury resulting from an acci|30| Kentucky Pharmacists Association | November/December 2019

Support KPPAC, KPhA Government Affairs Fund Today!

Now, more than ever, increased political involvement of pharmacists is a must if we are to be effective in our efforts to influence positive outcomes of legislation and regulations affecting the business and practice of pharmacy. The need is real and immediate for more pharmacists to make a financial commitment to the Kentucky Pharmacists Political Advocacy Council (KPPAC) and/or the KPhA Government Affairs Fund. Your donations will help KPhA and KPPAC be effective in the upcoming election season as well as the 2020 legislative session.

Please – consider making a donation today and, while you’re at it, think about making it a monthly investment in the future of pharmacy in Kentucky!

Donations to the KPPAC are vital to KPhA’s advocacy efforts by helping us strengthen relationships with key Kentucky legislators. Your commitment to advocacy makes sure pharmacy’s voice is heard loud and clear by Kentucky’s legislators.

Funds contributed to KPhA Government Affairs are applied directly to our lobbying efforts in terms of staffing and contracted lobbying services. Company donations are acceptable for Government Affairs contributions, unlike contributions to Political Advocacy Funds, like KPPAC.

|31| www.KPHANET.org

|32| Kentucky Pharmacists Association | November/December 2019

|33| www.KPHANET.org

KPhA BOARD OF DIRECTORS

mstutz@sullivan.edu

Chris Palutis, Lexington chris@candcrx.com

Chair

*At-Large Member to Executive Committee

Don Kupper, Louisville donku.ulh@gmail.com

President

KPERF BOARD OF DIRECTORS

Joel Thornbury, Pikeville jthorn6@gmail.com

President-Elect

Bob Oakley, Louisville rsoakley21@gmail.com

Chair

Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com

Secretary

Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu

Secretary

Chris Killmeier, Louisville cdkillmeier@hotmail.com

Treasurer

Chris Killmeier, Louisville cdkillmeier@hotmail.com

Treasurer

Chris Harlow, Louisville cpharlow@gmail.com

Past President Representative

Don Kupper, Louisville donku.ulh@gmail.com

President, KPhA

Kimberly Croley, Corbin kscroley@yahoo.com

Directors Angela Brunemann, Union Angbrunie@gmail.com

Kevin Lamping, Lexington kevin.lamping@twc.com

Matt Carrico, Louisville matt@boonevilledrugs.com

Paul Easley, Louisville rpeasley@bellsouth.net

Jessika Chilton, Beaver Dam jessikachilton@ymail.com Scotty Reams, London scotty.reams@uky.edu

Sarah Lawrence, Louisville slawrence@sullivan.edu University of Kentucky Student Representative

Chad Corum, Manchester pharmdky21@gmail.com

Mark Glasper Executive Director mglasper@kphanet.org

Cathy Hanna, Lexington channa@apscnet.com

Sarah Franklin Director of Communications & Continuing Education sarah@kphanet.org

Cassy Hobbs, Louisville cbeyerle01@gmail.com Anthony Seo, Louisville jseo0516@my.sullivan.edu Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Richard Slone, Hindman richardkslone@msn.com Ben Mudd, Lebanon* Speaker of the House bpmu222@gmail.com Martika Martin, Somerset Vice Speaker of the House 12marmar@gmail.com Misty Stutz, Crestwood

KPhA Staff

Sullivan University Student Representative

Angela Gibson Director of Finance & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Public Health jjaggers@kphanet.org Jessica Johnson, PharmD Director of Pharmacy Education Jessica@kphanet.org Michele Pinkston, PharmD, BCGP Director of Emergency Preparedness Michele@kphanet.org Lisa Atha Office Assistant/Member Services Coordinator latha@kphanet.org

|34| Kentucky Pharmacists Association | November/December 2019

“Jerome A. Budde, R.Ph., Ludlow, and Mrs. Gloria H. Doughty, R.Ph., Lexington, have been appointed to the Kentucky Board of Pharmacy by Governor Loui B. Nunn. The appointments were made in November.”

- From The Kentucky Pharmacist, December 1969, Volume XXXII, Number 12

Frequently Called and Contacted Kentucky Board of Pharmacy State Office Building Annex, Ste. 300

www.kshp.org info@kshp.org Kentucky Regional Poison Center

125 Holmes Street

(800) 222-1222

Frankfort, KY 40601

American Pharmacists Association (APhA)

(502) 564-7910 www.pharmacy.ky.gov Pharmacy Technician Certification Board (PTCB)

2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742

2215 Constitution Avenue

www.aphanet.org

Washington, DC 20037-2985

National Community Pharmacists Association (NCPA)

(800) 363-8012

National Association of Chain Drug Stores 1776 Wilson Blvd., Suite 200 Arlington, VA 22209 www.nacds.org 703-549-3001

100 Daingerfield Road

www.ptcb.org Kentucky Society of Health-System Pharmacists P.O. Box 4961 Louisville, KY 40204

Alexandria, VA 22314 (703) 683-8200 www.ncpanet.org info@ncpanet.org

(502) 456-1851 x2 (502) 456-1821 (fax)

KPhA/KPERF HEADQUARTERS 96 C Michael Davenport Blvd., Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) info@kphanet.org www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc

|35| www.KPHANET.org

THE

Kentucky PHARMACIST 96 C Michael Davenport Blvd.

Frankfort, KY 40601