Georgia Pharmacy Journal - June 2014

Page 1

June 2014 voluMe 36, issue 6

Rising to the

Challenge

Meet Bobby Moody GPhA President

2014-15

“I think my leadership style would be considered very hands-on.”

Plus

The GPhA Goes to Washington Deal Announces Medical Marijuana Project Drilling Down on Drug Errors off un r a in ress r e rt ng ca s co y u dd ge bu for pa

14


June 2014 Editor: Jim Bracewell jbracewell@gpha.org

The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2014, Georgia Pharmacy Association, Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording or information storage retrieval systems, without prior written permission from the publisher and managing editor. All views expressed in bylined articles are the opinions of the author and do not necessarily express the views or policies of the editors, officers or members of the Georgia Pharmacy Association.

Contents

2 Message from Jim Bracewell ......................... 4 Member News .................................................. 5 New GPhA Members ...................................... 7 Message from Pamala Marquess .................

Articles and Artwork Those interested in writing for this publication are encouraged to request the official “GPJ Guidelines for Writers.” Artists or photographers wishing to submit artwork for use on the cover should call, write or email jbracewell@gpha.org. Subscriptions and Change of Address The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is distributed as a regular membership service, paid for through allocation of membership dues. Subscription rate for non-members is $50.00 per year domestic and $10.00 per single copy; international rates $65.00 per year and $20.00 single copy. Subscriptions are not available for non-GPhA member pharmacists licensed and practicing in Georgia. The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is published monthly by the GPhA, 50 Lenox Pointe, NE, Atlanta, GA 30324. Periodicals postage paid at Atlanta, GA and additional offices. POSTMASTER: Send address changes to The Georgia Pharmacy Journal®, 50 Lenox Pointe, NE, Atlanta, GA 30324. Advertising Advertising copy deadline and rates are available upon request. All advertising and production orders should be sent to the GPhA headquarters at jbracewell@gpha.org.

10

Meet Bobby Moody, 2014-15 GPhA President ................

15 PharmPAC Supporters ................................18 Continuing Education ............................... 20 GPhA Board of Directors ......................... 28 Industry News ...............................................

GPhA Headquarters 50 Lenox Pointe, NE Atlanta, Georgia 30324 t 404-231-5074 f 404-237-8435

www.gpha.org

The Georgia Pharmacy Journal

1


June 2014 Editor: Jim Bracewell jbracewell@gpha.org

The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2014, Georgia Pharmacy Association, Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording or information storage retrieval systems, without prior written permission from the publisher and managing editor. All views expressed in bylined articles are the opinions of the author and do not necessarily express the views or policies of the editors, officers or members of the Georgia Pharmacy Association.

Contents

2 Message from Jim Bracewell ......................... 4 Member News .................................................. 5 New GPhA Members ...................................... 7 Message from Pamala Marquess .................

Articles and Artwork Those interested in writing for this publication are encouraged to request the official “GPJ Guidelines for Writers.” Artists or photographers wishing to submit artwork for use on the cover should call, write or email jbracewell@gpha.org. Subscriptions and Change of Address The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is distributed as a regular membership service, paid for through allocation of membership dues. Subscription rate for non-members is $50.00 per year domestic and $10.00 per single copy; international rates $65.00 per year and $20.00 single copy. Subscriptions are not available for non-GPhA member pharmacists licensed and practicing in Georgia. The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is published monthly by the GPhA, 50 Lenox Pointe, NE, Atlanta, GA 30324. Periodicals postage paid at Atlanta, GA and additional offices. POSTMASTER: Send address changes to The Georgia Pharmacy Journal®, 50 Lenox Pointe, NE, Atlanta, GA 30324. Advertising Advertising copy deadline and rates are available upon request. All advertising and production orders should be sent to the GPhA headquarters at jbracewell@gpha.org.

10

Meet Bobby Moody, 2014-15 GPhA President ................

15 PharmPAC Supporters ................................18 Continuing Education ............................... 20 GPhA Board of Directors ......................... 28 Industry News ...............................................

GPhA Headquarters 50 Lenox Pointe, NE Atlanta, Georgia 30324 t 404-231-5074 f 404-237-8435

www.gpha.org

The Georgia Pharmacy Journal

1


MESSAGE

from Pamala Marquess

All In a Year’s Work GPhA has a lot to celebrate! We have had a very exciting and success filled year. We had our share of challenges but were able to overcome these due to our incredible TEAM. The President’s first responsibility is to lead the Executive Committee(EC) retreat. The President plans the venue, topics, and agenda so as to produce a plan for the upcoming year. Pamala Marquess So, for inspiration, I chose grounds of higher learning in Athens since 1905. The University of GPhA President Georgia College of Pharmacy graciously was our host for this two and a half day intensive and strategic meeting. Each of your Executive Committee members; Robert Hatton, Bobby Moody, Tommy Whitworth, Lance Boles, and Jim Bracewell came as individuals with positive attitudes, ideas, opinions, and experiences and left as a unified team with a specific strategy focusing on: • Provider Status, • MAC pricing, • and expanding immunizations in Georgia. We performed a detailed review of the GPhA Bylaws and Constitution, GPhA Journal, finalized the calendar of events including EC monthly meetings, region meetings, BOD meetings, then discussed the legislative agenda, reviewed the 2014 convention plans and took individualized personality tests to identify strengths for the team. In July, the President is the representative for GPhA at the Georgia Society of Health System Pharmacists(GSHP) annual Board of Directors meeting. We had long and meaningful discussions about Provider Status, Legislative, and workplace issues, thus reinforcing our positive relationship with GSHP. My next weekend was equally as stimulating with the Academy of Independent Pharmacy’s (AIP) Board retreat. This board created a lengthy list of goals and objectives to continue their support of independent pharmacy’s growth and strength. Both GSHP and AIP are very important strategic partners with GPhA and of utmost importance to the Georgia Pharmacy Team. The first weekend of August, the EC attends the Southeastern Pharmacy Officers Conference. This year it was held in Nashville, TN, and to make efficient use of time, we rented a van and held our EC meeting during the drive to the meeting. This forum is a time for officers of the Southeastern states to share professional and legislative successes, network as well as challenge and strategize for the profession. We left this meeting inspired with the successes our colleagues were having and ideas we knew Georgia needed to address. Within two weeks, we took these ideas and shared them with the GPhA Board of Directors at their yearly Board retreat which happened at Chateau Elan in Braselton, GA last August. This Board took our challenges which included; membership, legislative initiatives, clinical and professional advancements, leadership advancements, and an Executive Vice President Transition policy. We addressed each topic as a Team with a unified voice. This finalized the direction for the remainder of the year and I appreciate the Board members for their dedication and professionalism during this year. Within a week, I boarded a plane for the International Pharmacy Federation (FIP) meeting in Dublin, Ireland. I traveled with the American Pharmacists Association President Steve Simenson, President Elect Matt Osterhaus, Trustee Jonathan Marquess, and EVP Tom Menighan. The focus of this meeting was on Integrated Care. This was my second FIP meeting and it always rings true that we live in a small world. I was able to see pharmacists from around the globe focusing on patient care with a similar approach. It is extremely important to learn from not only your own mistakes, but mistakes of others with processes and systems that we do not wish to implement at home. When I returned home, it was September and time for Standing Committee Meetings. I am especially proud of our Committee Chairs this year. Each had a long list of goals and objectives. We encouraged them to continue their work into a year round active committee. They took on these new objectives with strategic monthly conference calls with their committees as an effort to stay on track. This was very successful and meaningful to the members and also to the work of GPhA.

2

The Georgia Pharmacy Journal

This past October, the EC hit the road to see as many members as possible across our state with our Region Meetings. We actually visit more members during region meetings than we host at our annual meeting in June. This fall was no exception. The Region Presidents did an excellent job in planning, communicating, and encouraging attendance at the meetings. October is also the time for the NCPA annual meeting. Your President Elect, Bobby Moody, and I attended this meeting to represent you and the GPhA at this meeting. Our two Past Presidents of GPhA, John Sherrer and Hugh Chancy, are part of the NCPA leadership and we are proud of their national accomplishments and the manner in which they represent Georgia. After we finished fall region meetings and the holidays, the Board of Directors and Standing committee’s held its annual January meeting. This meeting serves to ensure the association is following the recommendations set forth by the various committees. This year’s meeting was very productive. The transition committee set a timeline for the hiring of a new GPhA Executive Vice President, the legislative agenda was reviewed, and the convention planning was ahead of schedule. February is a short month but was action packed! I attended the National Association of Chain Drug Stores (NACDS) meeting where the focus was on adherence, pharmacists making a difference, and the changing landscape of our profession. The most important event in February was our VIP day. We had another milestone in GPhA history! We had almost 500 attendees but more importantly, we had more pharmacists in attendance than ever before!! Governor Nathan Deal kicked off the morning by speaking to our group, which was followed by our keynote speaker Tom Menighan, CEO/EVP of APhA. We also had the honor of hearing from Lt. Governor Casey Cagle and many other dignitaries. But most importantly, you were there to make sure your voice was heard by your legislator! March was a time for Council of President’s meeting and GPhA Award nominee selections. This group is the think tank for the Association and we appreciate their input and wisdom. I have called on many of the Past Presidents to ask for advice and opinions and they have always been honest, forthright, and put GPhA at the fore-front of any discussion. March is also the time for the annual APhA meeting. This meeting is the most demanding of all the conferences as a GPhA President. President receptions, caucuses, House of Delegates, hosting a Georgia reception for all our alumni around the world, and attending sessions to learn new ideas to bring home to our members. I was honored to be asked to lead the Southeastern Caucus at this meeting. We discussed and debated critical issues in the profession. President Elect Bobby Moody and I attended this meeting on behalf of the EC. April and May brought a close to the Legislative session, region meetings and the NCPA Legislative Conference. Although our Legislative session did not bring the results we desired, we will never give up on fighting for patient access. This EC is committed to this outcome. President-Elect Bobby Moody and I, along with several AIP members, traveled to Washington DC and met with our Congressman to discuss issues important to Pharmacist and Patient access. The remainder of May was spent interviewing candidates for GPhA’s EVP position. The timeline was met, confidentiality was maintained and the process was nearly flawless. Again, I want to recognize the GPhA Board of Directors for their insightfulness, wisdom, and leadership. A final selection for an EVP has been decided and will be introduced at this year’s annual convention in June. I chose to highlight some of the more important events, but your Executive Committee has been involved in countless phone calls with members, meetings with your legislators, political fund raisers, conference calls, and weekend events. As I near the transition to Chairman of the Board, I am thankful for the hard work and dedication of the GPhA staff, legislative team, and Executive Committee. I would encourage everyone to remain involved with GPhA and to get involved in leadership. It is only two days a month! Yes, it requires time - your most valued treasure, but the rewards will far outweigh the sacrifice! Thank you for entrusting me to lead this Association. It has been my honor to serve each of you! Professionally yours,

Pam

Pamala S. Marquess

The Georgia Pharmacy Journal

3


MESSAGE

from Pamala Marquess

All In a Year’s Work GPhA has a lot to celebrate! We have had a very exciting and success filled year. We had our share of challenges but were able to overcome these due to our incredible TEAM. The President’s first responsibility is to lead the Executive Committee(EC) retreat. The President plans the venue, topics, and agenda so as to produce a plan for the upcoming year. Pamala Marquess So, for inspiration, I chose grounds of higher learning in Athens since 1905. The University of GPhA President Georgia College of Pharmacy graciously was our host for this two and a half day intensive and strategic meeting. Each of your Executive Committee members; Robert Hatton, Bobby Moody, Tommy Whitworth, Lance Boles, and Jim Bracewell came as individuals with positive attitudes, ideas, opinions, and experiences and left as a unified team with a specific strategy focusing on: • Provider Status, • MAC pricing, • and expanding immunizations in Georgia. We performed a detailed review of the GPhA Bylaws and Constitution, GPhA Journal, finalized the calendar of events including EC monthly meetings, region meetings, BOD meetings, then discussed the legislative agenda, reviewed the 2014 convention plans and took individualized personality tests to identify strengths for the team. In July, the President is the representative for GPhA at the Georgia Society of Health System Pharmacists(GSHP) annual Board of Directors meeting. We had long and meaningful discussions about Provider Status, Legislative, and workplace issues, thus reinforcing our positive relationship with GSHP. My next weekend was equally as stimulating with the Academy of Independent Pharmacy’s (AIP) Board retreat. This board created a lengthy list of goals and objectives to continue their support of independent pharmacy’s growth and strength. Both GSHP and AIP are very important strategic partners with GPhA and of utmost importance to the Georgia Pharmacy Team. The first weekend of August, the EC attends the Southeastern Pharmacy Officers Conference. This year it was held in Nashville, TN, and to make efficient use of time, we rented a van and held our EC meeting during the drive to the meeting. This forum is a time for officers of the Southeastern states to share professional and legislative successes, network as well as challenge and strategize for the profession. We left this meeting inspired with the successes our colleagues were having and ideas we knew Georgia needed to address. Within two weeks, we took these ideas and shared them with the GPhA Board of Directors at their yearly Board retreat which happened at Chateau Elan in Braselton, GA last August. This Board took our challenges which included; membership, legislative initiatives, clinical and professional advancements, leadership advancements, and an Executive Vice President Transition policy. We addressed each topic as a Team with a unified voice. This finalized the direction for the remainder of the year and I appreciate the Board members for their dedication and professionalism during this year. Within a week, I boarded a plane for the International Pharmacy Federation (FIP) meeting in Dublin, Ireland. I traveled with the American Pharmacists Association President Steve Simenson, President Elect Matt Osterhaus, Trustee Jonathan Marquess, and EVP Tom Menighan. The focus of this meeting was on Integrated Care. This was my second FIP meeting and it always rings true that we live in a small world. I was able to see pharmacists from around the globe focusing on patient care with a similar approach. It is extremely important to learn from not only your own mistakes, but mistakes of others with processes and systems that we do not wish to implement at home. When I returned home, it was September and time for Standing Committee Meetings. I am especially proud of our Committee Chairs this year. Each had a long list of goals and objectives. We encouraged them to continue their work into a year round active committee. They took on these new objectives with strategic monthly conference calls with their committees as an effort to stay on track. This was very successful and meaningful to the members and also to the work of GPhA.

2

The Georgia Pharmacy Journal

This past October, the EC hit the road to see as many members as possible across our state with our Region Meetings. We actually visit more members during region meetings than we host at our annual meeting in June. This fall was no exception. The Region Presidents did an excellent job in planning, communicating, and encouraging attendance at the meetings. October is also the time for the NCPA annual meeting. Your President Elect, Bobby Moody, and I attended this meeting to represent you and the GPhA at this meeting. Our two Past Presidents of GPhA, John Sherrer and Hugh Chancy, are part of the NCPA leadership and we are proud of their national accomplishments and the manner in which they represent Georgia. After we finished fall region meetings and the holidays, the Board of Directors and Standing committee’s held its annual January meeting. This meeting serves to ensure the association is following the recommendations set forth by the various committees. This year’s meeting was very productive. The transition committee set a timeline for the hiring of a new GPhA Executive Vice President, the legislative agenda was reviewed, and the convention planning was ahead of schedule. February is a short month but was action packed! I attended the National Association of Chain Drug Stores (NACDS) meeting where the focus was on adherence, pharmacists making a difference, and the changing landscape of our profession. The most important event in February was our VIP day. We had another milestone in GPhA history! We had almost 500 attendees but more importantly, we had more pharmacists in attendance than ever before!! Governor Nathan Deal kicked off the morning by speaking to our group, which was followed by our keynote speaker Tom Menighan, CEO/EVP of APhA. We also had the honor of hearing from Lt. Governor Casey Cagle and many other dignitaries. But most importantly, you were there to make sure your voice was heard by your legislator! March was a time for Council of President’s meeting and GPhA Award nominee selections. This group is the think tank for the Association and we appreciate their input and wisdom. I have called on many of the Past Presidents to ask for advice and opinions and they have always been honest, forthright, and put GPhA at the fore-front of any discussion. March is also the time for the annual APhA meeting. This meeting is the most demanding of all the conferences as a GPhA President. President receptions, caucuses, House of Delegates, hosting a Georgia reception for all our alumni around the world, and attending sessions to learn new ideas to bring home to our members. I was honored to be asked to lead the Southeastern Caucus at this meeting. We discussed and debated critical issues in the profession. President Elect Bobby Moody and I attended this meeting on behalf of the EC. April and May brought a close to the Legislative session, region meetings and the NCPA Legislative Conference. Although our Legislative session did not bring the results we desired, we will never give up on fighting for patient access. This EC is committed to this outcome. President-Elect Bobby Moody and I, along with several AIP members, traveled to Washington DC and met with our Congressman to discuss issues important to Pharmacist and Patient access. The remainder of May was spent interviewing candidates for GPhA’s EVP position. The timeline was met, confidentiality was maintained and the process was nearly flawless. Again, I want to recognize the GPhA Board of Directors for their insightfulness, wisdom, and leadership. A final selection for an EVP has been decided and will be introduced at this year’s annual convention in June. I chose to highlight some of the more important events, but your Executive Committee has been involved in countless phone calls with members, meetings with your legislators, political fund raisers, conference calls, and weekend events. As I near the transition to Chairman of the Board, I am thankful for the hard work and dedication of the GPhA staff, legislative team, and Executive Committee. I would encourage everyone to remain involved with GPhA and to get involved in leadership. It is only two days a month! Yes, it requires time - your most valued treasure, but the rewards will far outweigh the sacrifice! Thank you for entrusting me to lead this Association. It has been my honor to serve each of you! Professionally yours,

Pam

Pamala S. Marquess

The Georgia Pharmacy Journal

3


M E M B E R

The GPhA Goes to Washington

The Value of Your Voice

I was recently told a story of a man named Bob who lives in a city some distance from

his childhood home and was not able to get back home for his mother’s birthday. His mother is widowed and lives alone so Bob invested several hundred dollars to purchase a well-trained talking parrot for his mother to have as company. Several days after the parrot was delivered, Bob called to see how much she enjoyed the gift. “Mom... did you get the parrot I sent you and how do you like it?” Bob asked. His Jim Bracewell mother replied, “Yes, I got that beautiful bird and enjoyed it very much. It was delicious.” Executive Vice President Bob was stunned. “Mom! That parrot cost $600 dollars, spoke 200 words and you cooked it?,” Bob asked. His mom replied, “Well son... if the parrot was so smart he should have said something.” Last spring, I accompanied a wonderful young pharmacist on her visit to meet her legislator. We had a great meeting and the two really got acquainted. After this past legislative session, I went to visit that same legislator to find out why he did not support us on a certain issue. The frustrated legislator said he did not know the issue was important to pharmacy. “I did not hear anything about it from “You owe it to anyone back home in my district,” he stated. As a pharmacist and a member of the most over-regulated health yourself, to your profession in America you owe it to yourself, to your career, and to your career, and to profession to speak up. It is part of your role. It is part of your professionyour profession al responsibility. All too often the silent voice of pharmacy has led to the undervaluing of the profession and the underutilization of your scope of to speak up.” practice. This silence has led the public to think you can only count by five and run a computer with a phone in your ear. I’m sure that this is not the picture you want for the second most highly educated health profession in America. The moral of this story is that pharmacy is much like that beautiful, highly trained parrot. If we do not speak up for pharmacy, our future will be deliciously consumed by others as a result of our silence. Your voice is of great value. Do not squawk. Just make sure it’s heard. n

Jim

4

N E W S

The Georgia Pharmacy Journal

H

undreds of Independent Pharmacists from all over the USA went to DC for NCPA’s annual legislative conference including a dozen from Georgia. While there, they learned about issues that Congress is working to address to improve the profession of pharmacy. Some of the issues that were discussed included Preferred Network Fairness, Provider Status for Pharmacists and Generic Drug Pricing Transparency. The author of the Generic Drug Pricing Transparency Act, HR 4437, is no stranger to members of GPhA. It is former State Representative and now current Congressman from the 9th District of Georgia, Doug Collins. HR 4437 would allow a pharmacy to know how its individual maximum allowable cost (MAC) reimbursement rates for multisource generic drugs would be determined. It would also require payments to be updated more frequently to keep pace with actual market costs. In introducing the bill, Collins said: “A pharmacist often must provide crucial, very personal reassurance to their customers. A pharmacist can’t provide certainty to a patient if they’re operating with this kind of uncertainty about how much they’ll have to pay for their stock. This is something we can do to create transparency and fairness in how prescription drugs reach customers—our constituents.” Congressman Collins delivered the key note speech at the opening luncheon at the NCPA legislative conference. He shared his own positive experiences with pharmacists in his own district as well as the healthcare delivered to his family members by pharmacists. When not in workshops, GPhA members took to Capitol Hill to visit their Congressmen and Senators and ask for their support of important issues for pharmacists being addressed by Federal legislation. n

The Georgia Pharmacy Journal

Georgia Pharmacists with Georgia Congressman Doug Collins before he delivers his keynote address.

GPhA members Laird Miller, President Pam Marquess and Ira Katz discuss issues they learned at a NCPA workshop.

NCPA’s CEO Doug Hoey welcomes pharmacists to DC.

Real Financial Planning. No Generics.

It means having real strategies for all your financial issues, not just insurance and investments. It means working with a real planner who is experienced with the needs of pharmacists, their families and their practices. It means working with an independent firm you can trust. Michael T. Tarrant, CFP® • Speaker & Author • PharmPAC Supporter • Creating Real Financial Planning for over 20 Years

1117 Perimeter Center West, Suite N-307 • Atlanta, GA 30338 • 770-350-2455 • FNAplanners.com • mike@FNAplanners.com Registered Representative of INVEST Financial Corporation, member FINRA/SIPC. INVEST and its affiliated insurance agencies offer securities, advisory services and certain insurance products and are not affiliated with Financial Network Associates, Inc. Other advisory services offered through Financial Network Associates, Inc. ad.10040.110749


M E M B E R

The GPhA Goes to Washington

The Value of Your Voice

I was recently told a story of a man named Bob who lives in a city some distance from

his childhood home and was not able to get back home for his mother’s birthday. His mother is widowed and lives alone so Bob invested several hundred dollars to purchase a well-trained talking parrot for his mother to have as company. Several days after the parrot was delivered, Bob called to see how much she enjoyed the gift. “Mom... did you get the parrot I sent you and how do you like it?” Bob asked. His Jim Bracewell mother replied, “Yes, I got that beautiful bird and enjoyed it very much. It was delicious.” Executive Vice President Bob was stunned. “Mom! That parrot cost $600 dollars, spoke 200 words and you cooked it?,” Bob asked. His mom replied, “Well son... if the parrot was so smart he should have said something.” Last spring, I accompanied a wonderful young pharmacist on her visit to meet her legislator. We had a great meeting and the two really got acquainted. After this past legislative session, I went to visit that same legislator to find out why he did not support us on a certain issue. The frustrated legislator said he did not know the issue was important to pharmacy. “I did not hear anything about it from “You owe it to anyone back home in my district,” he stated. As a pharmacist and a member of the most over-regulated health yourself, to your profession in America you owe it to yourself, to your career, and to your career, and to profession to speak up. It is part of your role. It is part of your professionyour profession al responsibility. All too often the silent voice of pharmacy has led to the undervaluing of the profession and the underutilization of your scope of to speak up.” practice. This silence has led the public to think you can only count by five and run a computer with a phone in your ear. I’m sure that this is not the picture you want for the second most highly educated health profession in America. The moral of this story is that pharmacy is much like that beautiful, highly trained parrot. If we do not speak up for pharmacy, our future will be deliciously consumed by others as a result of our silence. Your voice is of great value. Do not squawk. Just make sure it’s heard. n

Jim

4

N E W S

The Georgia Pharmacy Journal

H

undreds of Independent Pharmacists from all over the USA went to DC for NCPA’s annual legislative conference including a dozen from Georgia. While there, they learned about issues that Congress is working to address to improve the profession of pharmacy. Some of the issues that were discussed included Preferred Network Fairness, Provider Status for Pharmacists and Generic Drug Pricing Transparency. The author of the Generic Drug Pricing Transparency Act, HR 4437, is no stranger to members of GPhA. It is former State Representative and now current Congressman from the 9th District of Georgia, Doug Collins. HR 4437 would allow a pharmacy to know how its individual maximum allowable cost (MAC) reimbursement rates for multisource generic drugs would be determined. It would also require payments to be updated more frequently to keep pace with actual market costs. In introducing the bill, Collins said: “A pharmacist often must provide crucial, very personal reassurance to their customers. A pharmacist can’t provide certainty to a patient if they’re operating with this kind of uncertainty about how much they’ll have to pay for their stock. This is something we can do to create transparency and fairness in how prescription drugs reach customers—our constituents.” Congressman Collins delivered the key note speech at the opening luncheon at the NCPA legislative conference. He shared his own positive experiences with pharmacists in his own district as well as the healthcare delivered to his family members by pharmacists. When not in workshops, GPhA members took to Capitol Hill to visit their Congressmen and Senators and ask for their support of important issues for pharmacists being addressed by Federal legislation. n

The Georgia Pharmacy Journal

Georgia Pharmacists with Georgia Congressman Doug Collins before he delivers his keynote address.

GPhA members Laird Miller, President Pam Marquess and Ira Katz discuss issues they learned at a NCPA workshop.

NCPA’s CEO Doug Hoey welcomes pharmacists to DC.

Real Financial Planning. No Generics.

It means having real strategies for all your financial issues, not just insurance and investments. It means working with a real planner who is experienced with the needs of pharmacists, their families and their practices. It means working with an independent firm you can trust. Michael T. Tarrant, CFP® • Speaker & Author • PharmPAC Supporter • Creating Real Financial Planning for over 20 Years

1117 Perimeter Center West, Suite N-307 • Atlanta, GA 30338 • 770-350-2455 • FNAplanners.com • mike@FNAplanners.com Registered Representative of INVEST Financial Corporation, member FINRA/SIPC. INVEST and its affiliated insurance agencies offer securities, advisory services and certain insurance products and are not affiliated with Financial Network Associates, Inc. Other advisory services offered through Financial Network Associates, Inc. ad.10040.110749


M E M B E R

N E W S

NCPA First Vice President Hugh Chancy is also a GPhA member.

Georgia Congressman Austin Scott raced back from the airport just to meet with GPhA members in DC.

your single source

for insurance protection

we will be there, standing beside you

from one generation to the next At Pharmacists Mutual, we are committed to building lasting relationships with our customers, always promising to focus on our members’ best interests. We are proud to be the leading provider of specialty commercial and personal insurance products and risk management services for the pharmacy profession. Give us a call, we look forward to partnering with you.

Hutton Madden

800.247.5930 ext. 7149 404.375.7209

Seth Swanson

800.247.5930 ext. 7128 850.688.3675

NCPA President Mark Riley gets the crowd fired up.

WELCOME

New Members Active Pharmacists

Julie Feltman – Chatsworth, GA Ana Cohen – Atlanta, GA Ann Moss – Rome, GA Sara Dasher – Claxton, GA Vickie Andros – Atlanta, GA Matthew Frazier – Macon, GA

Pharmacy Tech

Todd Reed, Jr. – Oakwood, GA

Member

RECOGNITION

Congratulations to Chancy Drugs in Valdosta on their Initial Accreditation for Non-Sterile Compounding by the Pharmacy Compounding Accreditation Board.

www.phmic.com

Not licensed to sell all product in all states.

Find us on Social Media: THE GEORGIA PHARMACY ASSOCIATION

The Georgia Pharmacy Journal

Independent Pharmacists from across America attended workshops about many issues facing pharmacy today.


M E M B E R

N E W S

NCPA First Vice President Hugh Chancy is also a GPhA member.

Georgia Congressman Austin Scott raced back from the airport just to meet with GPhA members in DC.

your single source

for insurance protection

we will be there, standing beside you

from one generation to the next At Pharmacists Mutual, we are committed to building lasting relationships with our customers, always promising to focus on our members’ best interests. We are proud to be the leading provider of specialty commercial and personal insurance products and risk management services for the pharmacy profession. Give us a call, we look forward to partnering with you.

Hutton Madden

800.247.5930 ext. 7149 404.375.7209

Seth Swanson

800.247.5930 ext. 7128 850.688.3675

NCPA President Mark Riley gets the crowd fired up.

WELCOME

New Members Active Pharmacists

Julie Feltman – Chatsworth, GA Ana Cohen – Atlanta, GA Ann Moss – Rome, GA Sara Dasher – Claxton, GA Vickie Andros – Atlanta, GA Matthew Frazier – Macon, GA

Pharmacy Tech

Todd Reed, Jr. – Oakwood, GA

Member

RECOGNITION

Congratulations to Chancy Drugs in Valdosta on their Initial Accreditation for Non-Sterile Compounding by the Pharmacy Compounding Accreditation Board.

www.phmic.com

Not licensed to sell all product in all states.

Find us on Social Media: THE GEORGIA PHARMACY ASSOCIATION

The Georgia Pharmacy Journal

Independent Pharmacists from across America attended workshops about many issues facing pharmacy today.


M E M B E R

N E W S

M E M B E R

N E W S

Chapman Healthcare Pharmacy and Wynn’s Pharmacy Enjoy Visits from Congressmen D

GPhA Academy of Independent Pharmacy Board members Tim Short, Laird Miller, Jeff Lurey, Ira Katz and Chris Thurmond pose for a quick picture on Capitol Hill.

Andy Freeman, Wes Chapman, Bobby Moody and Anna Plotkina had the opportunity to meet with Georgia Congressman Sanford Bishop.

Congressman Austin Scott welcomes GPhA members to his office.

Pharmacists learned about pharmacist candidates running for Congress while at the Legislative Conference.

8

GPhA-AIP Director Jeff Lurey is proud the Academy sponsored the opening luncheon, featuring Congressman Doug Collins.

The panelists encouraged a lot of dialogue with participants.

The Georgia Pharmacy Journal

uring a recent Congressional recess, GPhA members had members of Congress stopped by their pharmacies to talk about issues that are of importance to our profession. Congressman Lynn Westmoreland stopped by Wynn’s Pharmacy in Griffin Georgia and met with Carson Gleaton, Drew Miller, Kim Potter, Diane Brown, Blake Daniels, Nick Bland and David Clements. Congressman John Barrow made it a point to go to Chapman Healthcare Pharmacy in Vidalia while he was recently in his District. Both Congressmen Barrow and Westmoreland are members of the Congressional Pharmacy Caucus but want to know firsthand what goes on in the pharmacies “back home.” n

Congressman John Barrow visits with Wes Chapman at his pharmacy in Vidalia.

Congressman Lynn Westmoreland stopped by Wynn’s Pharmacy in Griffin.


M E M B E R

N E W S

M E M B E R

N E W S

Chapman Healthcare Pharmacy and Wynn’s Pharmacy Enjoy Visits from Congressmen D

GPhA Academy of Independent Pharmacy Board members Tim Short, Laird Miller, Jeff Lurey, Ira Katz and Chris Thurmond pose for a quick picture on Capitol Hill.

Andy Freeman, Wes Chapman, Bobby Moody and Anna Plotkina had the opportunity to meet with Georgia Congressman Sanford Bishop.

Congressman Austin Scott welcomes GPhA members to his office.

Pharmacists learned about pharmacist candidates running for Congress while at the Legislative Conference.

8

GPhA-AIP Director Jeff Lurey is proud the Academy sponsored the opening luncheon, featuring Congressman Doug Collins.

The panelists encouraged a lot of dialogue with participants.

The Georgia Pharmacy Journal

uring a recent Congressional recess, GPhA members had members of Congress stopped by their pharmacies to talk about issues that are of importance to our profession. Congressman Lynn Westmoreland stopped by Wynn’s Pharmacy in Griffin Georgia and met with Carson Gleaton, Drew Miller, Kim Potter, Diane Brown, Blake Daniels, Nick Bland and David Clements. Congressman John Barrow made it a point to go to Chapman Healthcare Pharmacy in Vidalia while he was recently in his District. Both Congressmen Barrow and Westmoreland are members of the Congressional Pharmacy Caucus but want to know firsthand what goes on in the pharmacies “back home.” n

Congressman John Barrow visits with Wes Chapman at his pharmacy in Vidalia.

Congressman Lynn Westmoreland stopped by Wynn’s Pharmacy in Griffin.


M E E T

B O B B Y

M E E T

M O O D Y

B O B B Y

M O O D Y

Rising to the

Challenge

Bobby has served the GPhA in many ways: as a student member, Region 6 President, member of the PharmPAC Board of Directors, GPhA’s 2nd Vice President and now GPhA President for 2014-15.

- Bobby Moody, GPhA President

2014-15

“I think my leadership style would be considered very hands-on.”

B

obby Moody did not always want to be a pharmacist. While growing up in Tifton, he wanted to become a doctor. “My grandfather was a doctor and I always wanted to help people like he did,” said Bobby. “Most of my family was in the healthcare business in some way,” he added. Bobby’s parents were nursing home administrators and from the age of 15 he worked in the nursing home doing odd jobs and always attended the nursing home association conventions with his parents. While attending Tift County High School he marched in the Blue Devil Brigade and was section leader his sophomore, junior and senior years. He also marched in the Redcoat Band at UGA and was featured on the football game program when the Bulldogs played Cal State Fullerton. “One day I talked to a friend from Tifton who was also thinking about going to medical school,” Bobby said. “The friend also mentioned pharmacy and I though it sounded like a great option.” While in pharmacy school at UGA, Bobby met his wife Sherri at a GPhA Convention and over the years they have

10

enjoyed the companionship of many pets including ferrets, cats, and dogs. They currently have 3 dogs (Snickers, Chunky, and Scooter) who travel most everywhere with them. He also enjoys playing golf, boating, salt water fishing, and as all his friends know... playing poker. “I intend to focus on past president Eddie Madden’s Strategic Plan of increasing membership and Pamela Mar-

The Georgia Pharmacy Journal

The Georgia Pharmacy Journal

quess’s new Leadership Advancement portion of the Strategic Plan,” says Bobby. “I believe we can increase membership by making sure every pharmacist in Georgia realizes that they are important to the profession, and that their involvement in the GPhA is important to their career,” he added. “I would also like to start a Leadership GPhA Program with 6-10 new practitioners to learn leadership skills

that would help them in their professional careers, personal life, and help them develop into future leaders of the GPhA.” Bobby’s leadership style could best be described as hands-on. He likes to get input from many sides and then decide the best course of action. In addition he looks forward to the day when pharmacists have provider status, when pharmacists can actually bill for

11


M E E T

B O B B Y

M E E T

M O O D Y

B O B B Y

M O O D Y

Rising to the

Challenge

Bobby has served the GPhA in many ways: as a student member, Region 6 President, member of the PharmPAC Board of Directors, GPhA’s 2nd Vice President and now GPhA President for 2014-15.

- Bobby Moody, GPhA President

2014-15

“I think my leadership style would be considered very hands-on.”

B

obby Moody did not always want to be a pharmacist. While growing up in Tifton, he wanted to become a doctor. “My grandfather was a doctor and I always wanted to help people like he did,” said Bobby. “Most of my family was in the healthcare business in some way,” he added. Bobby’s parents were nursing home administrators and from the age of 15 he worked in the nursing home doing odd jobs and always attended the nursing home association conventions with his parents. While attending Tift County High School he marched in the Blue Devil Brigade and was section leader his sophomore, junior and senior years. He also marched in the Redcoat Band at UGA and was featured on the football game program when the Bulldogs played Cal State Fullerton. “One day I talked to a friend from Tifton who was also thinking about going to medical school,” Bobby said. “The friend also mentioned pharmacy and I though it sounded like a great option.” While in pharmacy school at UGA, Bobby met his wife Sherri at a GPhA Convention and over the years they have

10

enjoyed the companionship of many pets including ferrets, cats, and dogs. They currently have 3 dogs (Snickers, Chunky, and Scooter) who travel most everywhere with them. He also enjoys playing golf, boating, salt water fishing, and as all his friends know... playing poker. “I intend to focus on past president Eddie Madden’s Strategic Plan of increasing membership and Pamela Mar-

The Georgia Pharmacy Journal

The Georgia Pharmacy Journal

quess’s new Leadership Advancement portion of the Strategic Plan,” says Bobby. “I believe we can increase membership by making sure every pharmacist in Georgia realizes that they are important to the profession, and that their involvement in the GPhA is important to their career,” he added. “I would also like to start a Leadership GPhA Program with 6-10 new practitioners to learn leadership skills

that would help them in their professional careers, personal life, and help them develop into future leaders of the GPhA.” Bobby’s leadership style could best be described as hands-on. He likes to get input from many sides and then decide the best course of action. In addition he looks forward to the day when pharmacists have provider status, when pharmacists can actually bill for

11


M E E T

B O B B Y

SUPPORT R.Ph PrimaryBUDDY RunoffCARTER is July 22. Visit with Buddy at the GPhA Convention - Booth #67 FOR CONGRESS

M O O D Y

services provided. “With the PBM’s underpaying for the cost of medications and decreasing fee payments, we need to work toward getting reimbursed for services we now provide for free,” he stated. Bobby has served the GPhA in many ways: as a student member, Region 6 President, member of the PharmPAC Board of Directors, GPhA’s 2nd Vice President and now GPhA President for 2014-15. Bobby also owns Powells Bloomfield Pharmacy, Arlington Rexall Drugs, and Coliseum Park Professional Pharmacy. His dedication and involvement in the GPhA and the pharmacy profession throughout the years have prepared him well to serve the Association as president. Bobby also realizes that to face the many challenges of pharmacy today, he needs your help. Bobby begins his term as president at the upcoming GPhA Convention and we hope all of you will congratulate him and join with him as we work together to enhance the profession of pharmacy. n

There is not a single Pharmacist serving in Congress. It’s time to change that. Please support Buddy Carter R.Ph for Congress. buddycarterforcongress.com/donate/ With all of the major changes taking place in the health care industry, now more than ever, we pharmacists must have our voices heard.

REAL SOLUTIONS. CONSERVATIVE PRINCIPLES.

Did we mention that Bobby is a Georgia Bulldog fan?

Corporate contributions and contributions by foreign nationals are prohibited. Individuals may contribute a maximum of $5,200 to the campaign- $2,600 for the primary election and $2,600 for the general election. PACS may contribute $10,000 to the campaign - $5,000 for the primary election and $5,000 for the general election. Federal law requires us to use our best efforts to collect and report the name, mailing address, occupation, and name of employer of each individual whose aggregate contributions exceed $200 in an election cycle. PAID FOR BY BUDDY CARTER FOR CONGRESS CARLTON HODGES, TREASURER

12

The Georgia Pharmacy Journal


M E E T

B O B B Y

SUPPORT R.Ph PrimaryBUDDY RunoffCARTER is July 22. Visit with Buddy at the GPhA Convention - Booth #67 FOR CONGRESS

M O O D Y

services provided. “With the PBM’s underpaying for the cost of medications and decreasing fee payments, we need to work toward getting reimbursed for services we now provide for free,” he stated. Bobby has served the GPhA in many ways: as a student member, Region 6 President, member of the PharmPAC Board of Directors, GPhA’s 2nd Vice President and now GPhA President for 2014-15. Bobby also owns Powells Bloomfield Pharmacy, Arlington Rexall Drugs, and Coliseum Park Professional Pharmacy. His dedication and involvement in the GPhA and the pharmacy profession throughout the years have prepared him well to serve the Association as president. Bobby also realizes that to face the many challenges of pharmacy today, he needs your help. Bobby begins his term as president at the upcoming GPhA Convention and we hope all of you will congratulate him and join with him as we work together to enhance the profession of pharmacy. n

There is not a single Pharmacist serving in Congress. It’s time to change that. Please support Buddy Carter R.Ph for Congress. buddycarterforcongress.com/donate/ With all of the major changes taking place in the health care industry, now more than ever, we pharmacists must have our voices heard.

REAL SOLUTIONS. CONSERVATIVE PRINCIPLES.

Did we mention that Bobby is a Georgia Bulldog fan?

Corporate contributions and contributions by foreign nationals are prohibited. Individuals may contribute a maximum of $5,200 to the campaign- $2,600 for the primary election and $2,600 for the general election. PACS may contribute $10,000 to the campaign - $5,000 for the primary election and $5,000 for the general election. Federal law requires us to use our best efforts to collect and report the name, mailing address, occupation, and name of employer of each individual whose aggregate contributions exceed $200 in an election cycle. PAID FOR BY BUDDY CARTER FOR CONGRESS CARLTON HODGES, TREASURER

12

The Georgia Pharmacy Journal


M E M B E R

N E W S

I N D U S T R Y

GPhA Member Buddy Carter Clinches First Place in May 20th Primary Runoff Set for July 22

G

Senator Buddy Carter and supporters intently watch early returns. have the 50% + 1 vote required by Georgia law to avoid a runoff election. Buddy ended up with almost twice the number of the votes cast for Dr. Bob Johnson and the two will meet on the ballot on Tuesday, July 22, 2014 for the runoff election. 20,000

Pharmacists have been excited about the prospect of having someone in Congress that understands how Government reimbursement rates effect their pharmacy and what PBMs are allowed to do when they are unregulated. n

18,959 Buddy Carter 36.23% Bob Johnson 22.71%

15,000 11,885

10,710

10,000 6,903 5,000

2,812 1,060

0 Senator Carter is interview by WASV Channel 3 as it becomes clear he will be the front runner in the primary.

14

Georgia to Team With Pharmaceutical Company On Medical Marijuana Project By Dave Williams: Staff Writer - Atlanta Business Chronicle

W

hen the Founding Fathers set up Congress, they wanted the House of Representatives to be the “People’s House” and have members from various walks of life. Today there are former professional athletes, a comedian, two almond orchard owners and a variety of other occupations making up the membership. When it comes to healthcare occupations 17 doctors, an optometrist, five nurses, three psychologists, two dentists, two veterinarians, one ophthalmologist and one psychiatrist but there are currently no pharmacists in the US House. As you may remember, when Congressman Jack Kingston announced his intention to run for the US Senate for the seat being vacated by the retiring Saxby Chambliss, a pharmacist, Buddy Carter declared his candidacy for the First Congressional District in Georgia. Buddy is a member of GPhA and AIP. He is a previous Mayor and State Representative and currently serves as a State Senator when he isn’t serving his patients at one of his three pharmacies. Buddy Carter received the most votes out of the six candidates on the May 20 Republican Primary ballot but did not

N E W S

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The Georgia Pharmacy Journal

overnor Nathan Deal is following through on plans he announced last month to launch clinical trials that could lead to the legal use of oil derived from the marijuana plant to treat children with epilepsy. The state of Georgia, Salisbury, England-based GW Pharmaceuticals and Georgia Regents University – the state’s medical college – have entered into an agreement to study Epidiolex, a non-psychoactive derivative of marijuana the company is working to develop. Families of children with epilepsy lobbied heavily during this year’s General Assembly session in support of legislation legalizing the use of cannabis

oil in Georgia for treatment of children with seizure disorders. Shortly after the bill died on the session’s last day, the governor announced he would try to find a way to make the safe and legal use of cannabis oil possible without waiting for lawmakers to return to the Capitol next winter. “I have learned the stories of brave Georgia families desperately seeking treatment for their children’s debilitating condition,” Deal said Tuesday. “As governor, it is my responsibility to address the needs of and protect our state’s most vulnerable citizens, especially when they are suffering. “I’m grateful to Georgia Regents Uni-

versity and GW Pharmaceuticals for their leadership on this venture, and I’m confident that this public-private partnership will deliver relief and improve quality of life for these children and their families.” The U.S. Food & Drug Administration has already authorized physician-sponsored Investigational New Drug programs with Epidiolex involving more than 300 children. In parallel, GW is undertaking a company-sponsored formal development program for Epidiolex focusing on the treatment of two rare and severe forms of childhood epilepsy: Dravet syndrome and Lennox-Gastaut syndrome. n


M E M B E R

N E W S

I N D U S T R Y

GPhA Member Buddy Carter Clinches First Place in May 20th Primary Runoff Set for July 22

G

Senator Buddy Carter and supporters intently watch early returns. have the 50% + 1 vote required by Georgia law to avoid a runoff election. Buddy ended up with almost twice the number of the votes cast for Dr. Bob Johnson and the two will meet on the ballot on Tuesday, July 22, 2014 for the runoff election. 20,000

Pharmacists have been excited about the prospect of having someone in Congress that understands how Government reimbursement rates effect their pharmacy and what PBMs are allowed to do when they are unregulated. n

18,959 Buddy Carter 36.23% Bob Johnson 22.71%

15,000 11,885

10,710

10,000 6,903 5,000

2,812 1,060

0 Senator Carter is interview by WASV Channel 3 as it becomes clear he will be the front runner in the primary.

14

Georgia to Team With Pharmaceutical Company On Medical Marijuana Project By Dave Williams: Staff Writer - Atlanta Business Chronicle

W

hen the Founding Fathers set up Congress, they wanted the House of Representatives to be the “People’s House” and have members from various walks of life. Today there are former professional athletes, a comedian, two almond orchard owners and a variety of other occupations making up the membership. When it comes to healthcare occupations 17 doctors, an optometrist, five nurses, three psychologists, two dentists, two veterinarians, one ophthalmologist and one psychiatrist but there are currently no pharmacists in the US House. As you may remember, when Congressman Jack Kingston announced his intention to run for the US Senate for the seat being vacated by the retiring Saxby Chambliss, a pharmacist, Buddy Carter declared his candidacy for the First Congressional District in Georgia. Buddy is a member of GPhA and AIP. He is a previous Mayor and State Representative and currently serves as a State Senator when he isn’t serving his patients at one of his three pharmacies. Buddy Carter received the most votes out of the six candidates on the May 20 Republican Primary ballot but did not

N E W S

Da

rw

in

r Ca

te

r Bu

dd

y

r Ca

te

r Je

ff

Ch

m ap

an Bo

bJ

n oh

so

n Ea

rl

r Ma

t in Jo

hn

M

a cC

llu

m

The Georgia Pharmacy Journal

overnor Nathan Deal is following through on plans he announced last month to launch clinical trials that could lead to the legal use of oil derived from the marijuana plant to treat children with epilepsy. The state of Georgia, Salisbury, England-based GW Pharmaceuticals and Georgia Regents University – the state’s medical college – have entered into an agreement to study Epidiolex, a non-psychoactive derivative of marijuana the company is working to develop. Families of children with epilepsy lobbied heavily during this year’s General Assembly session in support of legislation legalizing the use of cannabis

oil in Georgia for treatment of children with seizure disorders. Shortly after the bill died on the session’s last day, the governor announced he would try to find a way to make the safe and legal use of cannabis oil possible without waiting for lawmakers to return to the Capitol next winter. “I have learned the stories of brave Georgia families desperately seeking treatment for their children’s debilitating condition,” Deal said Tuesday. “As governor, it is my responsibility to address the needs of and protect our state’s most vulnerable citizens, especially when they are suffering. “I’m grateful to Georgia Regents Uni-

versity and GW Pharmaceuticals for their leadership on this venture, and I’m confident that this public-private partnership will deliver relief and improve quality of life for these children and their families.” The U.S. Food & Drug Administration has already authorized physician-sponsored Investigational New Drug programs with Epidiolex involving more than 300 children. In parallel, GW is undertaking a company-sponsored formal development program for Epidiolex focusing on the treatment of two rare and severe forms of childhood epilepsy: Dravet syndrome and Lennox-Gastaut syndrome. n


I N D U S T R Y

N E W S

I N D U S T R Y

Drilling Down on Drug Errors With any good risk management program, techniques must be put in place to minimize the potential for error.

O

ne of the staples of the Pharmacists Mutual Claims Study for the last decade or so has been the listing of the top 10 drugs delivered to patients in the Mechanical Error claims. Mechanical Errors are defined as providing the wrong drug, the wrong strength of the

right drug, or the wrong directions on the label. Mechanical Errors occur because of how our brains are wired and how we process information. They are not a refections of competence or intelligence. These “human errors” are the most common, making up 85% of the

2014 GPhA Convention

Play the Course That Jack Built. 1

th

5

AN

NUAL

Georgia Pharmacy Foundation

CARLTON HENDERSON MEMORIAL GOLF TOURNAMENT You work hard and you really care about your future in the pharmacy profession. That’s why you support The Georgia Pharmacy Association and attend the GPhA Convention. But you also deserve time to get out, enjoy one of the fantastic amenities at the convention and support a very worthy cause The Georgia Pharmacy Foundation Student Scholarship Program. Designed by the great Jack Nicklaus himself, this course is one of the best in Northwest Florida. So take a break and join us on the course that Jack built because as they say, “all work and no play makes Jack a dull boy.”

Friday, June 27, 2014 The Nicklaus Course at Bay Point Resort | Panama City Beach, FL

8.0% 7.0% 6.0% 5.0%

By Don McGuire, R.Ph., JD, General Council - Pharmacists Mutual Insurance claims in the study. With any good risk management program, techniques must be put in place to minimize the potential for error. In this article, we will go deeper into the data to help you better understand the risk potentials. The examples we will use from the top 11 drugs include warfarin, levothyroxine, insulin, oral hypoglycemics and prednisone. The inclusion on this list tells you that these drugs are problematic, but that, in and of itself, doesn’t give you much of a clue as to how they are problematic. Levothyroxine is delivered to patients in 5.7% of the Mechanical Errors claims, making it the second most common drug on the list. Simply telling the staff to be careful when dispensing levothyroxine is not very helpful. However, looking further at the data, we find that two-thirds of the time the wrong strength of levothyroxine is dispensed. This is not surprising considering that there are now 12 strengths available. It is also not surprising that only 3.6% of these claims involve the wrong directions since the once daily dose is so ubiquitous. While the 29% of patients who received levothyroxine when they should have received something else isn’t insignificant, it is more efficient to tackle the issue of wrong strength first. It focuses on one issue and gives the greatest potential for a reduction of errors. This same logic holds true for warfarin. Warfarin is delivered incorrectly in 7.1% of the claims. Again, most of these are delivering the wrong strengths of the 9 strengths available. This happens about 60% of the time. There is a little more variability in dosing, we see wrong direction errors increase to just over 12%. Patients received warfarin instead of their intended drug in 27.5% of claims.

The Georgia Pharmacy Journal

N E W S

4.0%

7.1% 5.7% 4.5% 3.5%

3.0% 2.0% 1.0% 0.0%

3.4%

3.3%

3.3%

3.2%

3.0%

2.7%

2.6%

3 categories at once if it were the only drug, or one of a few drugs, that we were approaching that way. Tackling all drugs that way would be too overwhelming. We might also start with the wrong strength situations since that makes up 42% of the claims. Another approach is to examine the error history in your practice setting specifically. Perhaps you vary from the broad sample that contributes to the Pharmacists Mutual Claims Study and a more specific problem will identify itself in your pharmacy. The data in our Claims Study is drawn form a wide variety of pharmacies. The value in examining it is that it provides a head start to any pharmacy’s risk management program by trying to learn from other’s mistakes. Specialty pharmacies experiences will likely be different. It is also valuable by providing information about where to attack the whole idea of dispensing errors. Telling someone to be more careful is not terribly effective alone. It is too broad. Telling them to make sure that the right strength of levothyroxine is being dispensed is more useful and effective. The key is to get started. Little victories inspire us too achieve greater victories. n

® ® ® l s e e l o l ulin in in s o ne i n e e t i c o p ri in t o on don d x v r n s d a o i a p n l e r b n o o i n I o c d m ia hy um /E oc Li s M e t xy u g Pr e ne ydr Co evot nti D O i A l / / l y H L A n o pt pr illi t ri c i i To ox Am Am As with levothyroxine, the greatest po- methylprednisolone, dexamethasone, tential reduction in errors will occur by and other steroids contribute to these errors. Patients received the wrong dose focusing on the strength dispensed. The data tells us we don’t want to use almost 42% of the time. Here there are this approach when we are dealing with 6 tablet strengths and 2 concentrations insulin and oral hypoglycemics. Deliver- of oral liquids that contribute to these ing the wrong strength of these drugs is errors. Prednisone is not a drug where not that frequent, 16% and 9.5% respec- we have on overwhelming “regular” tively. Insulin claims account for 3.3% of dose like levothyroxine does. The result our Mechanical Errors and oral hypo- is that wrong directions make up 22% of glycemics account for 4.5%. This 7.8% the prednisone errors. Different factors total is significant when the effectiveness make it so that no one category domiof these drugs’ actions is linked to them nates the type of errors committed. So how do we proceed with predbeing frequently dispensed incorrectly. For insulin, patients received the wrong nisone? We might be able to tackle all drug 71% of the time. For oral hypoglycemics, the frequency was a whopping 88.6%! The focus of these two groups of drugs should be making sure that the proper drug is being dispensed. Techniques that are useful here are “Show & Tell” counseling and the “NDC” Check. Again, focusing on the 1 of the 3 possible errors that gives the biggest return on efRepresenting pharmacists and pharmacies before fort increases the chance for the staff to the Georgia Pharmacy Board, GDNA and DEA. receive positive feedback. AREAS OF PRACTICE The last example is one where neither of the above approaches will work Professional Licensing Administrative Law best. Prednisone is the drug delivered Medicare and Medicaid Healthcare Law Fraud and Reimbursement in 3.2% of our Mechanical Error claims. Legal Advice for Criminal Defense Licensed Professionals For prednisone however, the types of errors involved are more scattered. Patients received the wrong drug in just WWW.FRANCULLEN.COM under 36% of claims. Prednisolone,

(404) 806-6771 • admin@francullen.com

The Georgia Pharmacy Journal


I N D U S T R Y

N E W S

I N D U S T R Y

Drilling Down on Drug Errors With any good risk management program, techniques must be put in place to minimize the potential for error.

O

ne of the staples of the Pharmacists Mutual Claims Study for the last decade or so has been the listing of the top 10 drugs delivered to patients in the Mechanical Error claims. Mechanical Errors are defined as providing the wrong drug, the wrong strength of the

right drug, or the wrong directions on the label. Mechanical Errors occur because of how our brains are wired and how we process information. They are not a refections of competence or intelligence. These “human errors” are the most common, making up 85% of the

2014 GPhA Convention

Play the Course That Jack Built. 1

th

5

AN

NUAL

Georgia Pharmacy Foundation

CARLTON HENDERSON MEMORIAL GOLF TOURNAMENT You work hard and you really care about your future in the pharmacy profession. That’s why you support The Georgia Pharmacy Association and attend the GPhA Convention. But you also deserve time to get out, enjoy one of the fantastic amenities at the convention and support a very worthy cause The Georgia Pharmacy Foundation Student Scholarship Program. Designed by the great Jack Nicklaus himself, this course is one of the best in Northwest Florida. So take a break and join us on the course that Jack built because as they say, “all work and no play makes Jack a dull boy.”

Friday, June 27, 2014 The Nicklaus Course at Bay Point Resort | Panama City Beach, FL

8.0% 7.0% 6.0% 5.0%

By Don McGuire, R.Ph., JD, General Council - Pharmacists Mutual Insurance claims in the study. With any good risk management program, techniques must be put in place to minimize the potential for error. In this article, we will go deeper into the data to help you better understand the risk potentials. The examples we will use from the top 11 drugs include warfarin, levothyroxine, insulin, oral hypoglycemics and prednisone. The inclusion on this list tells you that these drugs are problematic, but that, in and of itself, doesn’t give you much of a clue as to how they are problematic. Levothyroxine is delivered to patients in 5.7% of the Mechanical Errors claims, making it the second most common drug on the list. Simply telling the staff to be careful when dispensing levothyroxine is not very helpful. However, looking further at the data, we find that two-thirds of the time the wrong strength of levothyroxine is dispensed. This is not surprising considering that there are now 12 strengths available. It is also not surprising that only 3.6% of these claims involve the wrong directions since the once daily dose is so ubiquitous. While the 29% of patients who received levothyroxine when they should have received something else isn’t insignificant, it is more efficient to tackle the issue of wrong strength first. It focuses on one issue and gives the greatest potential for a reduction of errors. This same logic holds true for warfarin. Warfarin is delivered incorrectly in 7.1% of the claims. Again, most of these are delivering the wrong strengths of the 9 strengths available. This happens about 60% of the time. There is a little more variability in dosing, we see wrong direction errors increase to just over 12%. Patients received warfarin instead of their intended drug in 27.5% of claims.

The Georgia Pharmacy Journal

N E W S

4.0%

7.1% 5.7% 4.5% 3.5%

3.0% 2.0% 1.0% 0.0%

3.4%

3.3%

3.3%

3.2%

3.0%

2.7%

2.6%

3 categories at once if it were the only drug, or one of a few drugs, that we were approaching that way. Tackling all drugs that way would be too overwhelming. We might also start with the wrong strength situations since that makes up 42% of the claims. Another approach is to examine the error history in your practice setting specifically. Perhaps you vary from the broad sample that contributes to the Pharmacists Mutual Claims Study and a more specific problem will identify itself in your pharmacy. The data in our Claims Study is drawn form a wide variety of pharmacies. The value in examining it is that it provides a head start to any pharmacy’s risk management program by trying to learn from other’s mistakes. Specialty pharmacies experiences will likely be different. It is also valuable by providing information about where to attack the whole idea of dispensing errors. Telling someone to be more careful is not terribly effective alone. It is too broad. Telling them to make sure that the right strength of levothyroxine is being dispensed is more useful and effective. The key is to get started. Little victories inspire us too achieve greater victories. n

® ® ® l s e e l o l ulin in in s o ne i n e e t i c o p ri in t o on don d x v r n s d a o i a p n l e r b n o o i n I o c d m ia hy um /E oc Li s M e t xy u g Pr e ne ydr Co evot nti D O i A l / / l y H L A n o pt pr illi t ri c i i To ox Am Am As with levothyroxine, the greatest po- methylprednisolone, dexamethasone, tential reduction in errors will occur by and other steroids contribute to these errors. Patients received the wrong dose focusing on the strength dispensed. The data tells us we don’t want to use almost 42% of the time. Here there are this approach when we are dealing with 6 tablet strengths and 2 concentrations insulin and oral hypoglycemics. Deliver- of oral liquids that contribute to these ing the wrong strength of these drugs is errors. Prednisone is not a drug where not that frequent, 16% and 9.5% respec- we have on overwhelming “regular” tively. Insulin claims account for 3.3% of dose like levothyroxine does. The result our Mechanical Errors and oral hypo- is that wrong directions make up 22% of glycemics account for 4.5%. This 7.8% the prednisone errors. Different factors total is significant when the effectiveness make it so that no one category domiof these drugs’ actions is linked to them nates the type of errors committed. So how do we proceed with predbeing frequently dispensed incorrectly. For insulin, patients received the wrong nisone? We might be able to tackle all drug 71% of the time. For oral hypoglycemics, the frequency was a whopping 88.6%! The focus of these two groups of drugs should be making sure that the proper drug is being dispensed. Techniques that are useful here are “Show & Tell” counseling and the “NDC” Check. Again, focusing on the 1 of the 3 possible errors that gives the biggest return on efRepresenting pharmacists and pharmacies before fort increases the chance for the staff to the Georgia Pharmacy Board, GDNA and DEA. receive positive feedback. AREAS OF PRACTICE The last example is one where neither of the above approaches will work Professional Licensing Administrative Law best. Prednisone is the drug delivered Medicare and Medicaid Healthcare Law Fraud and Reimbursement in 3.2% of our Mechanical Error claims. Legal Advice for Criminal Defense Licensed Professionals For prednisone however, the types of errors involved are more scattered. Patients received the wrong drug in just WWW.FRANCULLEN.COM under 36% of claims. Prednisolone,

(404) 806-6771 • admin@francullen.com

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$300 minimum pledge *Renee Adamson, Pharm.D. Larry Batten, R. Ph. 11/14 Lance Boles, R.Ph. 8/14 Robert Cecil, R.Ph. 3/15 Laura Coker, Pharm D 6/14 *Ed Dozier, R.Ph. *Greg Drake, R. Ph. *Terry Dunn, R.Ph. *Marshall Frost, Pharm.D. *Amanda Gaddy, R. Ph. *Johnathan Hamrick, Pharm.D. *Willie Latch, R.Ph *Hilary Mbadugha, Pharm.D. The Georgia Pharmacy Journal

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No minimum pledge Claude Bates, R.Ph 6/14 Winston Brock, R.Ph. 6/14 David Carver, R.Ph. 6/14 Marshall Curtis, R.Ph. 6/14 Donley Dawson, Pharm.D. 12/14 John Drew, R.Ph. 6/14 James England, R.Ph. 6/14 Martin Grizzard, R.Ph. 12/14 Christopher Gurley, R. Ph. 6/14 Lise Hennick, R.Ph. 2/15 Marsha Kapiloff, R.Ph. 6/14 Charles Kovarik, R. Ph. 6/14 Ralph Marett, R.Ph. 6/14

Kenneth McCarthy, R.Ph. 6/14 Whitney Pickett, R.Ph. 11/14 Michael Reagan, R. Ph 6/14 Ola Reffell, R.Ph. 6/14 Leonard Reynolds, R.Ph. 6/14 Victor Serafy, R.Ph. 6/14 Harry Shurley, R.Ph 6/14 Jeff Smith, Pharm.D. 5/15 Amanda Stankiewicz, Student 6/14 Benjamin Stanley, R.Ph 6/14 Krista Stone, R.Ph 6/14 John Thomas, R.Ph. 11/14 William Thompson, R.Ph. 6/14 Carey Vaughan, Pharm.D. 6/14 Jonathon Williams R.Ph 8/14 *denotes sustaining members

NOTICE: Contact Andy Freeman, GPhA Director of Government Affairs, to update your support or if any information is incorrect. afreeman@gpha.org 404-419-8118

PharmPac Board of Directors

Eddie Madden, Chairman Dean Stone, Region 1 Keith Dupree, Region 2 Judson Mullican, Region 3 Bill McLeer, Region 4 Mahlon Davidson, Region 5 Mike McGee, Region 6 Jim McWilliams, Region 7 T.M. Bridges, Region 8 Mark Parris, Region 9 Chris Thurmond, Region 10 Stewart Flanagin, Region 11 Henry Josey, Region 12 Pam Marquess, Ex-Officio Jim Bracewell, Ex-Officio

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*Denotes a monthly sustaining PAC member. (Month/Year) Denotes most recent contribution.

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Platinum Level

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*Robert Hatton, Pharm.D. Ted Hunt, R.Ph.12/14 *Ira Katz, R.Ph. J. Thomas Lindsey, R.Ph. 4/15 Jeff Lurey, R.Ph. 12/14 *Eddie Madden, R.Ph. *Jonathan Marquess, Pharm.D. *Pam Marquess, Pharm.D. *Kenneth McCarthy, R.Ph. *Ivey McCurdy, Pharm. D *Drew Miller, R.Ph. *Laird Miller, R.Ph. *Jay Mosley, R.Ph. *Sujal Patel, Pharm D *Mark Parris, Pharm.D. *Allen Partridge, R.Ph. *Houston Rogers, Pharm.D. Tim Short, R.Ph. 10/14 *Benjamin Stanley, Pharm.D. *Danny Toth, R.Ph. *Christopher Thurmond, Pharm.D. *Alex Tucker, Pharm.D. Lindsay Walker, R.Ph. 6/14 Henry Wilson, Pharm.D. 11/14

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Highlight denotes new and increased contributors.

*Kerry Griffin, R.Ph. *Michael Iteogu, R.Ph. *Joshua Kinsey, Pharm.D. *Dan Kiser, R.Ph. *Allison Layne, C.Ph.T Lance LoRusso 6/14 Michael McGee, R.Ph. 4/15 *Sheila Miller, Pharm.D. *Robert Moody, R.Ph. *Sherri Moody, Pharm.D. *William Moye, R.Ph. *Anthony Ray, R.Ph. *Jeffrey Richardson, R.Ph. *Andy Rogers, R.Ph. Daniel Royal, R.Ph. 5/15 *Michael Tarrant *James Thomas, R.Ph. Zach Tomberlin, Pharm.D. 4/15 *Mark White, R.Ph. *Charles Wilson Jr., R.Ph.

*Kalen Manasco, Pharm.D. Max Mason, R.Ph. 3/15 *William McLeer, R.Ph. *Sheri Mills, C.Ph.T. *Richard Noell, R.Ph. *Darby Norman, R.Ph. *Cynthia Piela, R.Ph. *Donald Piela, Jr. Pharm.D. Bill Prather, R.Ph. 6/14 *Kristy Pucylowski, Pharm.D. *Edward Reynolds, R.Ph. *Ashley Rickard, Pharm D. *Brian Rickard, Pharm D. Brian Scott, R.Ph. 5/15 Richard Smith, R.Ph. 5/15 Flynn Warren, R.Ph. 6/14 Steve Wilson, Pharm.D. 7/14 *William Wolfe, R.Ph. *Sharon Zerillo, R.Ph.

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$150 minimum pledge Monica Ali-Warren, R.Ph. 6/14 *Shane Bentley, Student *Robert Bowles *Mike Crooks, Pharm.D. *Rabun Dekle, R. Ph. Becky Hamilton, Pharm.D. 4/15 *Larry Harkleroad, R.Ph. Winton Harris Jr., R.Ph. 6/14 *Hannah Head, Pharm.D. *Amy Grimsley, Pharm.D. *Thomas Jeter, R.Ph. *Henry Josey, Pharm.D. *Brenton Lake, R.Ph. *Tracie Lunde, Pharm.D.

$300 minimum pledge *Renee Adamson, Pharm.D. Larry Batten, R. Ph. 11/14 Lance Boles, R.Ph. 8/14 Robert Cecil, R.Ph. 3/15 Laura Coker, Pharm D 6/14 *Ed Dozier, R.Ph. *Greg Drake, R. Ph. *Terry Dunn, R.Ph. *Marshall Frost, Pharm.D. *Amanda Gaddy, R. Ph. *Johnathan Hamrick, Pharm.D. *Willie Latch, R.Ph *Hilary Mbadugha, Pharm.D. The Georgia Pharmacy Journal

Bronze Level

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*Michael Lewis, Pharm.D. *Susan McLeer, R.Ph. Judson Mullican, R.Ph. 11/14 *Natalie Nielsen, R.Ph. *Mark Niday, R. Ph. *Don Richie, R.Ph. *Amanda Paisley, Pharm.D. Rose Pinkstaff, R.Ph. 1/15 *Alex Pinkston IV, R.Ph Don Richie, R.Ph. 11/14 *Corey Rieck Carlos Rodriguez-Feo, R.Ph. 12/14 *Laurence Ryan, Pharm.D. *Olivia Santoso, Pharm. D. Wade Scott, R.Ph. 5/15 James Stowe, R.Ph. 12/14 *Dana Strickland, R.Ph. G.H. Thurmond, R.Ph. 11/14 *Tommy Tolbert, R. Ph. *Austin Tull, Pharm.D.

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No minimum pledge Claude Bates, R.Ph 6/14 Winston Brock, R.Ph. 6/14 David Carver, R.Ph. 6/14 Marshall Curtis, R.Ph. 6/14 Donley Dawson, Pharm.D. 12/14 John Drew, R.Ph. 6/14 James England, R.Ph. 6/14 Martin Grizzard, R.Ph. 12/14 Christopher Gurley, R. Ph. 6/14 Lise Hennick, R.Ph. 2/15 Marsha Kapiloff, R.Ph. 6/14 Charles Kovarik, R. Ph. 6/14 Ralph Marett, R.Ph. 6/14

Kenneth McCarthy, R.Ph. 6/14 Whitney Pickett, R.Ph. 11/14 Michael Reagan, R. Ph 6/14 Ola Reffell, R.Ph. 6/14 Leonard Reynolds, R.Ph. 6/14 Victor Serafy, R.Ph. 6/14 Harry Shurley, R.Ph 6/14 Jeff Smith, Pharm.D. 5/15 Amanda Stankiewicz, Student 6/14 Benjamin Stanley, R.Ph 6/14 Krista Stone, R.Ph 6/14 John Thomas, R.Ph. 11/14 William Thompson, R.Ph. 6/14 Carey Vaughan, Pharm.D. 6/14 Jonathon Williams R.Ph 8/14 *denotes sustaining members

NOTICE: Contact Andy Freeman, GPhA Director of Government Affairs, to update your support or if any information is incorrect. afreeman@gpha.org 404-419-8118

PharmPac Board of Directors

Eddie Madden, Chairman Dean Stone, Region 1 Keith Dupree, Region 2 Judson Mullican, Region 3 Bill McLeer, Region 4 Mahlon Davidson, Region 5 Mike McGee, Region 6 Jim McWilliams, Region 7 T.M. Bridges, Region 8 Mark Parris, Region 9 Chris Thurmond, Region 10 Stewart Flanagin, Region 11 Henry Josey, Region 12 Pam Marquess, Ex-Officio Jim Bracewell, Ex-Officio

19


continuing education for pharmacists Volume XXXII, No. 4

Advances in the Treatment of Pulmonary Hypertension: Focus on Adempas and Opsumit Thomas A. Gossel, R.Ph., Ph.D., Professor Emeritus, Ohio Northern University, Ada, Ohio Dr. Thomas A. Gossel has no relevant financial relationships to disclose.

Goal. The goal of this lesson is to provide information on pulmonary hypertension and its therapy, with emphasis on two recently approved drugs, macitentan (Opsumit®) and riociguat (Adempas®). Objectives. At the completion of this activity, the participant will be able to: 1. recognize signs and symptoms, and key features of pulmonary hypertension including information on its prevalence; 2. identify the drugs by generic name, trade name, and chemical name when relevant; 3. recognize the indication(s), pharmacologic action(s), clinical application(s), and route of administration for each drug; 4. demonstrate an understanding of adverse effects and toxicity, warnings, precautions, contraindications, and significant drug-drug interactions; and 5. list important information to convey to patients and/or their caregivers. Pulmonary hypertension (PH) is a hemodynamic and pathophysiologic condition. Both progressive and debilitating, with a median survival of only 2.8 years following diagnosis if left untreated, PH is defined as mean pulmonary artery pressure (mPAP) of 25 mmHg or greater at rest. The normal mPAP is 12 to 16 mmHg. Patients with PH have a sustained increase in

20

pulmonary arterial pressure that results from excessive vasoconstriction of the pulmonary arteries. The workload of the heart’s right ventricle is therefore increased, leading to its failure and, eventually, death. Treatment of PH is largely palliative, and disease progression continues despite availability of drugs that are specific for the disorder. This lesson reviews PH and provides a brief introduction to

the drugs used in its treatment with focus on two newly approved therapies. The lesson is not meant to extend beyond an overview of the topic. The reader is, therefore, urged to consult the products’ full Prescribing Information leaflet (package insert), Medication Guide, and other published reference sources for detailed descriptions.

Background

The World Health Organiza-

Table 1 WHO categories of pulmonary hypertension Group 1 pulmonary arterial hypertension includes: •PAH that has no known cause (idiopathic) •PAH that is inherited (genetic) •PAH caused by drugs or toxins, such as street drugs and certain diet medications •PAH caused by conditions such as connective tissue diseases, HIV infection, liver infection, chronic hemolytic anemia, sickle cell disease, schistosomiasis (one of the most common causes of PAH in many parts of the world) •PAH caused by conditions that affect the pulmonary vasculature Group 2 pulmonary hypertension includes: •PH due to left heart disease. Conditions that affect the left side of the heart, such as mitral valve disease or long-term hypertension, can cause left heart disease and PH. Left heart disease is likely the most common cause of PH. Group 3 pulmonary hypertension includes: •PH associated with lung disease and/or hypoxia, such as COPD* and interstitial lung diseases. Interstitial lung diseases cause scarring of lung tissue. Group 3 also includes PH associated with sleep-disordered breathing, chronic exposure to high altitude, and developmental abnormalities. Group 4 pulmonary hypertension includes: •PH caused by chronic thromboembolic disease characterized by obstruction of the pulmonary vasculature by residual organized thrombi, leading to increased pulmonary vascular resistance, progressive PH, and right ventricular failure Group 5 pulmonary hypertension includes: •PH caused by various other diseases or conditions. Examples include blood diseases such as polycythemia vera, thrombocythemia; systemic disorders such as sarcoidosis, vasculitis; and metabolic disorders such as thyroid disease and glycogen storage disease •PH caused by other conditions such as tumors that press on the pulmonary arteries and kidney disease *COPD – chronic obstructive pulmonary disease

The Georgia Pharmacy Journal

Table 2 WHO functional classification for patients with pulmonary hypertension Class Description I Patients with PH but without resulting limitations of physical activity; ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope II Patients with PH resulting in slight limitation of physical activity; they are comfortable at rest; ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope III Patients with PH resulting in marked limitation of physical activity; they are comfortable at rest; less-than-ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope IV Patients with PH with an inability to carry out any physical activity without symptoms; these patients manifest signs of right heart failure; dyspnea and/or fatigue can even be present at rest; discomfort is increased by any physical activity

tion (WHO) recognizes a number of etiologies that cause PH and divides them into five categories of disease (Table 1). These groups are organized based on the cause of PH and treatment options. Note that Group 1 is referred to as pulmonary arterial hypertension (PAH) and Groups 2 through 5 are called pulmonary hypertension. However, together, all Groups are collectively called pulmonary hypertension. In addition to the etiological classification of PH, patients can also be classified according to their functional abilities and symptom severity (Table 2). The WHO classification of functional capacity is modeled after the New York Heart Association’s classification system for heart failure and is commonly used in both daily practice and clinical trials to describe patients. The WHO functional class is determined from the patient’s own

The Georgia Pharmacy Journal

subjective impression of physical ability and symptom severity. The indications for FDA-approved treatments of PH specify the WHO classification. The terms “primary” and “secondary” PH are historical and even though they are still mentioned informally in association with the various forms of the disease, their use is now discouraged. The terms suggest clinically inappropriate groupings of the disorders and may thus promote inadequate therapeutic decision making. Pathogenesis. Left heart disease is the most common cause of PH. There is, however, a relative lack of data on the frequency of pathologic pulmonary vascular changes in this heterogeneous group of patients. WHO Group 1 PAH is predominantly a disease of the distal pulmonary arteries (i.e., pulmonary artery vasculopathy). Associated pathology includes pulmonary arterial vasoconstriction, medial hypertrophy, intimal proliferation and fibrosis, complex plexiform lesions, and thrombotic lesions. Pathologic changes in PAH typically onset as a compensated phase characterized by abnormal pulmonary artery endothelium, pulmonary arterial vasoconstriction and stiffening, loss of microvessels, and right ventricle hypertrophy. As PAH progresses, pulmonary vascular intimal proliferation, obliterative pulmonary artery remodeling, and pulmonary vascular fibrosis occur and eventually progress to right ventricle dilation and failure. Symptoms. Progressive dyspnea is the most common symptom of PH, being the initial symptom in greater than half of patients with PH. It ultimately appears in approximately 85 percent of patients. Since exertional dyspnea is a common symptom of multiple cardiopulmonary pathologies, and PH is relatively uncommon with many primary care physicians never encountering a case, clinicians need a high index of suspicion to correctly identify patients with the condition, especially those

who present at a younger age and patients diagnosed with concurrent asthma. Even as awareness of the disease has increased over the past two decades, delay from symptom onset to diagnosis is still considerable, with 20 percent of patients experiencing symptoms for longer than two years before a diagnosis of PH is made and treatment is initiated. Other symptoms include fatigue (26 percent), chest pain (22 percent), lower-extremity edema (20 percent), presyncope/syncope (17 percent), and palpitations (12 percent). As PH worsens, patients may find it difficult to undertake any physical activity. A rare symptom known as the Ortner syndrome is characterized by onset of hoarseness from compression of the left laryngeal nerve by an enlarged pulmonary artery. Prognosis. PH is considered a negative prognostic sign in many pathologic conditions, including the most commonly associated ones, such as heart failure and chronic obstructive pulmonary disease (COPD). For heart failure, elevated pulmonary arterial pressure on right heart catheterization is a powerful predictor of premature mortality, particularly in the setting of myocarditis or decreased right ventricular ejection fraction. Likewise, patients with COPD and more severe PH have a poorer prognosis. Treatment directed at PH has not been linked to improved outcomes in either of these pathologic conditions. As noted earlier, the prognosis of untreated PH is poor, with a median survival of 2.8 years, and an estimated one-year survival of only 68 percent. Treatment with approved therapies has improved survival and quality of life, if initiated early in the course of the disease. But PH continues to be a life threatening condition.

Treatment of Pulmonary Hypertension

Appropriate treatment for PH relies on identification of its cause. For persons with chronic cardiac

21


continuing education for pharmacists Volume XXXII, No. 4

Advances in the Treatment of Pulmonary Hypertension: Focus on Adempas and Opsumit Thomas A. Gossel, R.Ph., Ph.D., Professor Emeritus, Ohio Northern University, Ada, Ohio Dr. Thomas A. Gossel has no relevant financial relationships to disclose.

Goal. The goal of this lesson is to provide information on pulmonary hypertension and its therapy, with emphasis on two recently approved drugs, macitentan (Opsumit®) and riociguat (Adempas®). Objectives. At the completion of this activity, the participant will be able to: 1. recognize signs and symptoms, and key features of pulmonary hypertension including information on its prevalence; 2. identify the drugs by generic name, trade name, and chemical name when relevant; 3. recognize the indication(s), pharmacologic action(s), clinical application(s), and route of administration for each drug; 4. demonstrate an understanding of adverse effects and toxicity, warnings, precautions, contraindications, and significant drug-drug interactions; and 5. list important information to convey to patients and/or their caregivers. Pulmonary hypertension (PH) is a hemodynamic and pathophysiologic condition. Both progressive and debilitating, with a median survival of only 2.8 years following diagnosis if left untreated, PH is defined as mean pulmonary artery pressure (mPAP) of 25 mmHg or greater at rest. The normal mPAP is 12 to 16 mmHg. Patients with PH have a sustained increase in

20

pulmonary arterial pressure that results from excessive vasoconstriction of the pulmonary arteries. The workload of the heart’s right ventricle is therefore increased, leading to its failure and, eventually, death. Treatment of PH is largely palliative, and disease progression continues despite availability of drugs that are specific for the disorder. This lesson reviews PH and provides a brief introduction to

the drugs used in its treatment with focus on two newly approved therapies. The lesson is not meant to extend beyond an overview of the topic. The reader is, therefore, urged to consult the products’ full Prescribing Information leaflet (package insert), Medication Guide, and other published reference sources for detailed descriptions.

Background

The World Health Organiza-

Table 1 WHO categories of pulmonary hypertension Group 1 pulmonary arterial hypertension includes: •PAH that has no known cause (idiopathic) •PAH that is inherited (genetic) •PAH caused by drugs or toxins, such as street drugs and certain diet medications •PAH caused by conditions such as connective tissue diseases, HIV infection, liver infection, chronic hemolytic anemia, sickle cell disease, schistosomiasis (one of the most common causes of PAH in many parts of the world) •PAH caused by conditions that affect the pulmonary vasculature Group 2 pulmonary hypertension includes: •PH due to left heart disease. Conditions that affect the left side of the heart, such as mitral valve disease or long-term hypertension, can cause left heart disease and PH. Left heart disease is likely the most common cause of PH. Group 3 pulmonary hypertension includes: •PH associated with lung disease and/or hypoxia, such as COPD* and interstitial lung diseases. Interstitial lung diseases cause scarring of lung tissue. Group 3 also includes PH associated with sleep-disordered breathing, chronic exposure to high altitude, and developmental abnormalities. Group 4 pulmonary hypertension includes: •PH caused by chronic thromboembolic disease characterized by obstruction of the pulmonary vasculature by residual organized thrombi, leading to increased pulmonary vascular resistance, progressive PH, and right ventricular failure Group 5 pulmonary hypertension includes: •PH caused by various other diseases or conditions. Examples include blood diseases such as polycythemia vera, thrombocythemia; systemic disorders such as sarcoidosis, vasculitis; and metabolic disorders such as thyroid disease and glycogen storage disease •PH caused by other conditions such as tumors that press on the pulmonary arteries and kidney disease *COPD – chronic obstructive pulmonary disease

The Georgia Pharmacy Journal

Table 2 WHO functional classification for patients with pulmonary hypertension Class Description I Patients with PH but without resulting limitations of physical activity; ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope II Patients with PH resulting in slight limitation of physical activity; they are comfortable at rest; ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope III Patients with PH resulting in marked limitation of physical activity; they are comfortable at rest; less-than-ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope IV Patients with PH with an inability to carry out any physical activity without symptoms; these patients manifest signs of right heart failure; dyspnea and/or fatigue can even be present at rest; discomfort is increased by any physical activity

tion (WHO) recognizes a number of etiologies that cause PH and divides them into five categories of disease (Table 1). These groups are organized based on the cause of PH and treatment options. Note that Group 1 is referred to as pulmonary arterial hypertension (PAH) and Groups 2 through 5 are called pulmonary hypertension. However, together, all Groups are collectively called pulmonary hypertension. In addition to the etiological classification of PH, patients can also be classified according to their functional abilities and symptom severity (Table 2). The WHO classification of functional capacity is modeled after the New York Heart Association’s classification system for heart failure and is commonly used in both daily practice and clinical trials to describe patients. The WHO functional class is determined from the patient’s own

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subjective impression of physical ability and symptom severity. The indications for FDA-approved treatments of PH specify the WHO classification. The terms “primary” and “secondary” PH are historical and even though they are still mentioned informally in association with the various forms of the disease, their use is now discouraged. The terms suggest clinically inappropriate groupings of the disorders and may thus promote inadequate therapeutic decision making. Pathogenesis. Left heart disease is the most common cause of PH. There is, however, a relative lack of data on the frequency of pathologic pulmonary vascular changes in this heterogeneous group of patients. WHO Group 1 PAH is predominantly a disease of the distal pulmonary arteries (i.e., pulmonary artery vasculopathy). Associated pathology includes pulmonary arterial vasoconstriction, medial hypertrophy, intimal proliferation and fibrosis, complex plexiform lesions, and thrombotic lesions. Pathologic changes in PAH typically onset as a compensated phase characterized by abnormal pulmonary artery endothelium, pulmonary arterial vasoconstriction and stiffening, loss of microvessels, and right ventricle hypertrophy. As PAH progresses, pulmonary vascular intimal proliferation, obliterative pulmonary artery remodeling, and pulmonary vascular fibrosis occur and eventually progress to right ventricle dilation and failure. Symptoms. Progressive dyspnea is the most common symptom of PH, being the initial symptom in greater than half of patients with PH. It ultimately appears in approximately 85 percent of patients. Since exertional dyspnea is a common symptom of multiple cardiopulmonary pathologies, and PH is relatively uncommon with many primary care physicians never encountering a case, clinicians need a high index of suspicion to correctly identify patients with the condition, especially those

who present at a younger age and patients diagnosed with concurrent asthma. Even as awareness of the disease has increased over the past two decades, delay from symptom onset to diagnosis is still considerable, with 20 percent of patients experiencing symptoms for longer than two years before a diagnosis of PH is made and treatment is initiated. Other symptoms include fatigue (26 percent), chest pain (22 percent), lower-extremity edema (20 percent), presyncope/syncope (17 percent), and palpitations (12 percent). As PH worsens, patients may find it difficult to undertake any physical activity. A rare symptom known as the Ortner syndrome is characterized by onset of hoarseness from compression of the left laryngeal nerve by an enlarged pulmonary artery. Prognosis. PH is considered a negative prognostic sign in many pathologic conditions, including the most commonly associated ones, such as heart failure and chronic obstructive pulmonary disease (COPD). For heart failure, elevated pulmonary arterial pressure on right heart catheterization is a powerful predictor of premature mortality, particularly in the setting of myocarditis or decreased right ventricular ejection fraction. Likewise, patients with COPD and more severe PH have a poorer prognosis. Treatment directed at PH has not been linked to improved outcomes in either of these pathologic conditions. As noted earlier, the prognosis of untreated PH is poor, with a median survival of 2.8 years, and an estimated one-year survival of only 68 percent. Treatment with approved therapies has improved survival and quality of life, if initiated early in the course of the disease. But PH continues to be a life threatening condition.

Treatment of Pulmonary Hypertension

Appropriate treatment for PH relies on identification of its cause. For persons with chronic cardiac

21


Table 3 Advanced therapies for pulmonary hypertension Drug Class Prostacyclin analogues Epoprostenol (Flolan, Veletri) Iloprost (Ventavis) Treprostinil (Remodulin, Tyvaso)

Mechanism of Action Stimulates intracellular production of cAMP±

Endothelin-receptor antagonists Ambrisentan (Letairis) Bosentan (Tracleer)

Blocks endothelin-1 receptors on vascular smooth muscle

Phosphodiesterase-5 inhibitors Sildenafil (Revatio, Viagra*) Tadalafil (Adcirca, Cialis*)

Inhibits breakdown of cGMP§ in vascular smooth muscle

cAMP – cyclic adenosine monophosphate § cGMP – cyclic guanosine monophosphate *Cialis and Viagra are not indicated for treatment of PH ±

or pulmonary disease, therapy is largely focused on treating the underlying condition. To date, the majority of drug development in PH has been focused on patients with WHO Group 1 PAH. Approved therapies fall into one of three classes of pulmonary vasodilators: (1) prostacyclin analogues, (2) endothelin receptor antagonists (ERAs), and (3) phosphodiesterase-5 inhibitors. These are collectively termed “advanced therapies” (Table 3), and are available for oral, inhaled, subcutaneous, and intravenous administration. Each therapy targets a different cellular pathway implicated in the pathogenesis of PAH. Prostacyclin Analogues. Prostacyclin is also referred to as prostaglandin I2 (PGI2). Prostacyclins were the first available targeted treatment for PAH and are at present considered the cornerstone of therapy. They have potent vasodilatory, antiplatelet, and antiproliferative properties on the pulmonary vasculature and their synthesis is reduced in patients with PAH. Synthetic prostacyclin derivatives augment decreased prostacyclin levels. Endothelin Receptor Antagonists. Endothelin is a potent vasoconstrictor and stimulator of smooth muscle cell proliferation. It contributes to the regulation of

22

vascular tone by binding to ETA and ETB receptor subtypes in the pulmonary vasculature. Activation of ETA receptors results in vasoconstriction and cellular proliferation. Pharmacotherapeutic influence in these reactions, therefore, is a primary target of ERAs. ETB is thought to have a regulatory effect on endothelin; however, the clinical relevance of blocking this receptor is unknown. Endothelin may be overexpressed in patients with PAH and, hence, is an important drug target. Risks related to treatment with ERAs are well known, and include elevations in liver aminotransferases and edema. Their effect on the liver is possibly a class effect and necessitates monitoring of liver function in patients treated with these compounds. The voluntary withdrawal from the world market of the ERA, sitaxsentan, with cessation of all ongoing clinical trials because of cases of unpredictable serious liver injury, illustrates the need for new compounds that have reduced hepatic liability. The drug was never approved in the United States. Similarly, a reduced risk of edema would constitute a major advance and would allow for the application of ERAs in other diseases. This is demonstrated by recent findings with the experimental

ERA, darusentan, in patients with treatment-resistant hypertension. While darusentan provided additional reduction in blood pressure in patients in whom hypertension could not be controlled adequately with available drugs, edema occurred in 27 percent of patients compared with 14 percent in patients treated with placebo. The drug’s future for approval in the United States remains in question at present. The mechanism by which ERAs induce liver aminotransferases is unknown. It has been hypothesized that inhibition of the bile salt export pump, a transporter protein involved in mediating secretion of bile salts across the canalicular plasma membrane of hepatocytes, results in intracellular accumulation of bile salts with subsequent hepatic injury. The occurrence of edema is possibly caused by circulating endothelin-1 via activation of the ETB receptor, suggesting that ERAs that block both ETA and ETB receptors are less prone to causing edema. Phosphodiesterase Type-5 Inhibitors. Phosphodiesterase type-5 (PDE-5) inhibitors work via the nitric oxide (NO) pathway. They are responsible for the degradation of cyclic guanosine monophosphate (cGMP), which plays an important role in regulating processes that influence vascular tone, proliferation, fibrosis, and inflammation. PH is associated with impaired NO release and reduction of cGMP concentration in the pulmonary tissue. PDE-5s increase cGMP concentration resulting in relaxation of the smooth muscle cells leading to vasodilation of the pulmonary vessels. Intracellular cGMP plays an important role in regulating processes that influence vascular tone, proliferation, fibrosis, and inflammation. PH is associated with endothelial dysfunction, impaired synthesis of NO, and insufficient stimulation of the NO-sGC-cGMP pathway. Combination Therapy. The current status of PH treatment is based on sequential addition of

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advanced therapies. Therapy is chosen initially by assessing illness severity and patient functional class, along with integrating patient preferences and adverse effect profiles of the medications being considered. If PH worsens despite optimum dosing of a single agent, additional therapies from different pharmacologic groups are usually added until treatment goals are reached.

Extending Survival and Quality of Life

A significant number of patients with PH experience little or no improvement despite available therapies, and mortality remains high despite treatment. There is, therefore, an unmet need for drugs that extend survival and improve quality of life in PH patients, while also having a favorable safety profile and a convenient mode of administration. New drugs with novel mechanisms of action are at various levels of development. At present, clinicians are challenged not by having too few therapeutic options, but by having to choose among the various treatments available, monitoring patients for stability, and recognizing when to escalate pharmacotherapy or consider surgical options (lung transplantation or atrial septostomy). Atrial septostomy is a surgical procedure in which a small hole is created between the heart’s two atria. This relieves some of the pressure within the pulmonary vasculature, but at the expense of reduced oxygen levels in the heart (hypoxia). Goals of Therapy. The goals of therapy are to prevent advancement of the disease; decrease hospital admissions; and improve quality of life (decreased symptoms), WHO functional class (increased activity levels), hemodynamics, 6-minute walk results, and overall survival. Specific PH therapy is usually started for symptomatic patients in WHO functional classes II, III, or IV if they fail to show no acute vasoreactivity or if they did not maintain an acceptable sus-

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tained response to calcium channel blockers. General supportive measures are listed in Table 4.

Recently Approved Drugs

Two new drugs for PH were approved in October 2013 (Table 5). The two drugs differ in their basic pharmacology, but both share one troublesome toxicologic effect – they both may cause fetal harm when administered to pregnant females. Because of this potential toxicity, female patients can receive the new drugs only through the manufacturers’ Risk Evaluation and Mitigation Strategy (REMS) program. All female patients must be enrolled in the program, comply with pregnancy testing requirements and be counseled regarding the need for effective contraception. The REMS restricted distribution program requires prescribers to be certified by enrolling in the program. Also, pharmacies must be certified and can dispense the new drugs only to patients who are eligible to receive it. Males need not be enrolled in the program.

Riociguat (Adempas)

Indications and Use. Adempas (a-dem-pahs) was the first drug of any class to be shown to be effective for patients with chronic thromboembolic PH (CTEPH). It is indicated for treatment of adults with persistent/recurrent CTEPH (WHO Group 4) following surgical treatment or inoperable CTEPH, to improve exercise capacity and WHO functional class. It is also indicated to treat PAH (WHO Group 1), to improve exercise capacity, improve WHO functional class, and to delay clinical worsening. Mechanism of Action. Riociguat has a dual mode of action. It sensitizes sGC to endogenous NO by stabilizing the NO-sGC binding. The drug also directly stimulates sGC via a different binding site, independently of NO. The drug stimulates the NO-sGC-cGMP pathway and leads to increased generation of cGMP with subsequent vasodilation. The active metabolite of

Table 4 General supportive measures for patients with pulmonary hypertension General recommendations •Symptom-limited exercise •Avoid hypobaric environments, including high-altitude travel •Avoid medications with vasoconstrictive properties (e.g., pseudoephedrine) •Discourage pregnancy due to high maternal mortality •Avoid oral contraceptives with prothrombotic properties Medical therapy •Anticoagulation to a target INR of 1.5 to 2.5; recommended for most patients •Oxygen supplementation for hypoxemia •Diuretics for management of edema or fluid retention, especially in the setting of right ventricular failure •Consider digoxin, particularly for patients with a high sympathetic activation or with concomitant atrial fibrillation or biventricular failure •Long-term calcium channel blockers for patients who have a genuine acute vasoreactivity test and calcium channel blocker challenge without significant side effect, (fewer than 7 percent of patients are in this subgroup)

riociguat is 1/3 to 1/10 as potent as the parent drug in vitro. Efficacy and Safety. Safety and effectiveness of Adempas to treat CTEPH were established in a clinical trial with 261 participants randomized to take Adempas with the dose gradually increased up to 2.5 mg three times daily, or to receive a placebo three times daily. The study was designed to measure the change in distance a patient could walk in six minutes. After 16 weeks of treatment, the average improvement in a six-minute walk distance in participants treated with Adempas was 46 meters (about 150 feet) more than in those treated with placebo. The clinical trial evaluating the safety and effectiveness of Adempas to treat PAH included 443 participants randomly assigned to

23


Table 3 Advanced therapies for pulmonary hypertension Drug Class Prostacyclin analogues Epoprostenol (Flolan, Veletri) Iloprost (Ventavis) Treprostinil (Remodulin, Tyvaso)

Mechanism of Action Stimulates intracellular production of cAMP±

Endothelin-receptor antagonists Ambrisentan (Letairis) Bosentan (Tracleer)

Blocks endothelin-1 receptors on vascular smooth muscle

Phosphodiesterase-5 inhibitors Sildenafil (Revatio, Viagra*) Tadalafil (Adcirca, Cialis*)

Inhibits breakdown of cGMP§ in vascular smooth muscle

cAMP – cyclic adenosine monophosphate § cGMP – cyclic guanosine monophosphate *Cialis and Viagra are not indicated for treatment of PH ±

or pulmonary disease, therapy is largely focused on treating the underlying condition. To date, the majority of drug development in PH has been focused on patients with WHO Group 1 PAH. Approved therapies fall into one of three classes of pulmonary vasodilators: (1) prostacyclin analogues, (2) endothelin receptor antagonists (ERAs), and (3) phosphodiesterase-5 inhibitors. These are collectively termed “advanced therapies” (Table 3), and are available for oral, inhaled, subcutaneous, and intravenous administration. Each therapy targets a different cellular pathway implicated in the pathogenesis of PAH. Prostacyclin Analogues. Prostacyclin is also referred to as prostaglandin I2 (PGI2). Prostacyclins were the first available targeted treatment for PAH and are at present considered the cornerstone of therapy. They have potent vasodilatory, antiplatelet, and antiproliferative properties on the pulmonary vasculature and their synthesis is reduced in patients with PAH. Synthetic prostacyclin derivatives augment decreased prostacyclin levels. Endothelin Receptor Antagonists. Endothelin is a potent vasoconstrictor and stimulator of smooth muscle cell proliferation. It contributes to the regulation of

22

vascular tone by binding to ETA and ETB receptor subtypes in the pulmonary vasculature. Activation of ETA receptors results in vasoconstriction and cellular proliferation. Pharmacotherapeutic influence in these reactions, therefore, is a primary target of ERAs. ETB is thought to have a regulatory effect on endothelin; however, the clinical relevance of blocking this receptor is unknown. Endothelin may be overexpressed in patients with PAH and, hence, is an important drug target. Risks related to treatment with ERAs are well known, and include elevations in liver aminotransferases and edema. Their effect on the liver is possibly a class effect and necessitates monitoring of liver function in patients treated with these compounds. The voluntary withdrawal from the world market of the ERA, sitaxsentan, with cessation of all ongoing clinical trials because of cases of unpredictable serious liver injury, illustrates the need for new compounds that have reduced hepatic liability. The drug was never approved in the United States. Similarly, a reduced risk of edema would constitute a major advance and would allow for the application of ERAs in other diseases. This is demonstrated by recent findings with the experimental

ERA, darusentan, in patients with treatment-resistant hypertension. While darusentan provided additional reduction in blood pressure in patients in whom hypertension could not be controlled adequately with available drugs, edema occurred in 27 percent of patients compared with 14 percent in patients treated with placebo. The drug’s future for approval in the United States remains in question at present. The mechanism by which ERAs induce liver aminotransferases is unknown. It has been hypothesized that inhibition of the bile salt export pump, a transporter protein involved in mediating secretion of bile salts across the canalicular plasma membrane of hepatocytes, results in intracellular accumulation of bile salts with subsequent hepatic injury. The occurrence of edema is possibly caused by circulating endothelin-1 via activation of the ETB receptor, suggesting that ERAs that block both ETA and ETB receptors are less prone to causing edema. Phosphodiesterase Type-5 Inhibitors. Phosphodiesterase type-5 (PDE-5) inhibitors work via the nitric oxide (NO) pathway. They are responsible for the degradation of cyclic guanosine monophosphate (cGMP), which plays an important role in regulating processes that influence vascular tone, proliferation, fibrosis, and inflammation. PH is associated with impaired NO release and reduction of cGMP concentration in the pulmonary tissue. PDE-5s increase cGMP concentration resulting in relaxation of the smooth muscle cells leading to vasodilation of the pulmonary vessels. Intracellular cGMP plays an important role in regulating processes that influence vascular tone, proliferation, fibrosis, and inflammation. PH is associated with endothelial dysfunction, impaired synthesis of NO, and insufficient stimulation of the NO-sGC-cGMP pathway. Combination Therapy. The current status of PH treatment is based on sequential addition of

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advanced therapies. Therapy is chosen initially by assessing illness severity and patient functional class, along with integrating patient preferences and adverse effect profiles of the medications being considered. If PH worsens despite optimum dosing of a single agent, additional therapies from different pharmacologic groups are usually added until treatment goals are reached.

Extending Survival and Quality of Life

A significant number of patients with PH experience little or no improvement despite available therapies, and mortality remains high despite treatment. There is, therefore, an unmet need for drugs that extend survival and improve quality of life in PH patients, while also having a favorable safety profile and a convenient mode of administration. New drugs with novel mechanisms of action are at various levels of development. At present, clinicians are challenged not by having too few therapeutic options, but by having to choose among the various treatments available, monitoring patients for stability, and recognizing when to escalate pharmacotherapy or consider surgical options (lung transplantation or atrial septostomy). Atrial septostomy is a surgical procedure in which a small hole is created between the heart’s two atria. This relieves some of the pressure within the pulmonary vasculature, but at the expense of reduced oxygen levels in the heart (hypoxia). Goals of Therapy. The goals of therapy are to prevent advancement of the disease; decrease hospital admissions; and improve quality of life (decreased symptoms), WHO functional class (increased activity levels), hemodynamics, 6-minute walk results, and overall survival. Specific PH therapy is usually started for symptomatic patients in WHO functional classes II, III, or IV if they fail to show no acute vasoreactivity or if they did not maintain an acceptable sus-

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tained response to calcium channel blockers. General supportive measures are listed in Table 4.

Recently Approved Drugs

Two new drugs for PH were approved in October 2013 (Table 5). The two drugs differ in their basic pharmacology, but both share one troublesome toxicologic effect – they both may cause fetal harm when administered to pregnant females. Because of this potential toxicity, female patients can receive the new drugs only through the manufacturers’ Risk Evaluation and Mitigation Strategy (REMS) program. All female patients must be enrolled in the program, comply with pregnancy testing requirements and be counseled regarding the need for effective contraception. The REMS restricted distribution program requires prescribers to be certified by enrolling in the program. Also, pharmacies must be certified and can dispense the new drugs only to patients who are eligible to receive it. Males need not be enrolled in the program.

Riociguat (Adempas)

Indications and Use. Adempas (a-dem-pahs) was the first drug of any class to be shown to be effective for patients with chronic thromboembolic PH (CTEPH). It is indicated for treatment of adults with persistent/recurrent CTEPH (WHO Group 4) following surgical treatment or inoperable CTEPH, to improve exercise capacity and WHO functional class. It is also indicated to treat PAH (WHO Group 1), to improve exercise capacity, improve WHO functional class, and to delay clinical worsening. Mechanism of Action. Riociguat has a dual mode of action. It sensitizes sGC to endogenous NO by stabilizing the NO-sGC binding. The drug also directly stimulates sGC via a different binding site, independently of NO. The drug stimulates the NO-sGC-cGMP pathway and leads to increased generation of cGMP with subsequent vasodilation. The active metabolite of

Table 4 General supportive measures for patients with pulmonary hypertension General recommendations •Symptom-limited exercise •Avoid hypobaric environments, including high-altitude travel •Avoid medications with vasoconstrictive properties (e.g., pseudoephedrine) •Discourage pregnancy due to high maternal mortality •Avoid oral contraceptives with prothrombotic properties Medical therapy •Anticoagulation to a target INR of 1.5 to 2.5; recommended for most patients •Oxygen supplementation for hypoxemia •Diuretics for management of edema or fluid retention, especially in the setting of right ventricular failure •Consider digoxin, particularly for patients with a high sympathetic activation or with concomitant atrial fibrillation or biventricular failure •Long-term calcium channel blockers for patients who have a genuine acute vasoreactivity test and calcium channel blocker challenge without significant side effect, (fewer than 7 percent of patients are in this subgroup)

riociguat is 1/3 to 1/10 as potent as the parent drug in vitro. Efficacy and Safety. Safety and effectiveness of Adempas to treat CTEPH were established in a clinical trial with 261 participants randomized to take Adempas with the dose gradually increased up to 2.5 mg three times daily, or to receive a placebo three times daily. The study was designed to measure the change in distance a patient could walk in six minutes. After 16 weeks of treatment, the average improvement in a six-minute walk distance in participants treated with Adempas was 46 meters (about 150 feet) more than in those treated with placebo. The clinical trial evaluating the safety and effectiveness of Adempas to treat PAH included 443 participants randomly assigned to

23


Table 5 New drugs for treatment of pulmonary hypertension Generic Name

Distributor

Indication

Dose

Dosage Form

Macitentan (Opsumit)

Actelion Pharmaceuticals US, Inc.

PAH* (WHO Group 1)

10 mg once daily

10 mg tablets

Riociguat (Adempas)

Bayer HealthCare Pharmaceuticals Inc.

PAH* (WHO Group 1); CTEPH± (WHO Group 4)

1 mg 0.5 mg, 1 mg, three 1.5 mg, 2 mg, times and 2.5 mg daily (range: 0.5 mg to 2.5 mg three times daily)

Medication Guide

Yes

Yes

*PAH – Pulmonary Arterial Hypertension ± CTEPH – Chronic Thromboembolic Pulmonary Hypertension

take the drug at a dose of 1.5 mg or 2.5 mg, or placebo, three times daily. After 12 weeks of treatment, the 6-minute walk distance in patients treated with Adempas improved by an average of 36 meters (about 118 feet) more than in patients treated with placebo. Common adverse effects observed in patients treated with Adempas included headache, dizziness, indigestion, tissue swelling, nausea, diarrhea, and vomiting. Warnings, Precautions and Contraindications. The following warnings and precautions are listed. •Symptomatic hypotension: Adempas reduces blood pressure. Consider dose reductions if the patient develops signs or symptoms of hypotension. •Bleeding: Serious hemorrhagic events can occur. Monitor patient for signs and symptoms. •Pulmonary edema in patients with pulmonary veno-occlusive disease: Discontinue treatment if confirmed. •A boxed warning advises that the drug should not be used during pregnancy, and that the drug is available only through a restricted distribution program. Three contraindications are listed: pregnancy, use with nitrates or NO donors in any form (e.g., amyl nitrite), and use with phosphodiesterase inhibitors (e.g.,

24

dipyridamole, theophylline, sildenafil, tadalafil, vardenafil). Drug Interactions. Noted specifically are strong CYP and Pglycoprotein/breast cancer resistance protein (P-gp/BCRP) inhibitors. For patients receiving strong CYP and P-gp/BCRP inhibitors (e.g., ketoconazole, itraconazole, ritonavir), consider a starting dose of 0.5 mg three times a day. Monitor for hypotension. Antacids such as aluminum- or magnesium hydroxide decrease riociguat absorption, so doses of antacids and riociguat should be separated by at least one hour. Administration, Dosing, and Counseling. Initiate treatment at 1 mg three times a day. For patients who may not tolerate the hypotensive effect, consider a starting dose of 0.5 mg three times a day. Dosage may be increased by 0.5 mg intervals of no sooner than two weeks as tolerated, to a maximum dose of 2.5 mg three times a day. If a dose is missed, continue with the next regularly scheduled dose. In the event that Adempas dosing is interrupted for three or more days, re-titrate the drug. Plasma concentrations are reduced 50 to 60 percent in smokers. Consider titrating to dosages higher than 2.5 mg three times a day if tolerated in patients who smoke to match exposure seen in non-smokers. A decrease in dosage

Table 6 Patient information for riociguat (Adempas)* Patients: •should read the Medication Guide carefully and talk with their pharmacist or physician if they have questions. •(females) should use emergency contraception in the event of unprotected sex or contraceptive failure. Females must sign an enrollment form to register in the Adempas REMS Program; males are not required to do so. •(pre-pubertal females) should report any changes in her reproductive status immediately to her prescriber. •should be aware of the potential risks/signs of coughing up blood caused by the drug, and must contact their physician right away if signs/ symptoms appear. •should be aware it is important to stick closely to the dosing, titration, and maintenance of Adempas. If a dose is missed, patients should continue with the next regularly scheduled dose. In event the drug is interrupted for three or more days, the dose should be re-titrated. •should report all current medicines and new medicines to their physician. •should not take antacids within one hour of taking Adempas. •should be aware Adempas can cause dizziness, which can affect the ability to drive and use machines. •should be aware they should not use Adempas for a condition other than for what it was prescribed, or give it to other people, even if their symptoms are the same. •should be aware that Adempas should be stored at room temperature between 59oF to 86oF (15oC to 30oC). *Summarized from the FDAapproved Medication Guide

may be required in patients who stop smoking. Adempas is available in tablets containing 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg of riociguat. Specific points for counseling are summarized in Table 6.

Macitentan (Opsumit)

Opsumit (OP-sum-it) is the second new drug approved during October, 2013 for treatment of PH.

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Table 7 Patient information for macitentan (Opsumit)* Patients: •should read the Medication Guide carefully and talk with their pharmacist or physician if they have questions. •(females) may experience fetal harm when Opsumit is used during pregnancy. Instruct females to use effective contraception and to contact her physician if she suspects she may be pregnant. Females must sign an enrollment form to register in the Opsumit REMS Program; males are not required to do so. •(pre-pubertal females) should report any changes in her reproductive status immediately to her prescriber. •should get hemoglobin levels tested as the physician recommends. •should be aware the drug may interfere with spermatogenesis. •should be aware of signs of hepatotoxicity, and contact their doctor if they have unexplained nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching. •should not split, crush, or chew Opsumit tablets. •should store Opsumit tablets at 20oC to 25oC (68oF to 77oF), with excursions permitted between 15oC and 30oC (59oF and 86oF) *Summarized from the FDAapproved Medication Guide.

Indications and Use. The new drug is an ERA indicated for treatment of PAH (WHO Group 1) to delay disease progression. During clinical trials, disease progression included: death, initiation of intravenous or subcutaneous prostanoids, or clinical worsening of PAH (decreased six-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). The new drug also reduced hospitalizations for PAH. Mechanism of Action. Endothelin (ET)-1 and its receptors (ETA and ETB) mediate a variety of deleterious effects, such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation. In

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disease conditions such as PAH, the local ET system is upregulated and is involved in vascular hypertrophy and in organ damage. Macitentan is an ERA with high lipophilicity that prevents the binding of ET-1 to both ETA and ETB receptors. The dual ERA was developed by modifying the structure of bosentan (Tracleer) to increase efficacy and safety. The new drug is characterized by sustained receptor binding and enhanced tissue penetration. Macitentan displays high affinity and sustained occupancy of the ET receptors in human pulmonary arterial smooth muscle cells. One of the metabolites of macitentan is also pharmacologically active at the ET receptors and is estimated to be about 20 percent as potent as the parent drug in vitro. Efficacy and Safety. Safety and effectiveness were established primarily in one long-term clinical trial where 742 participants were randomly assigned to take Opsumit or placebo. The average treatment duration was about two years. In the study, Opsumit was effective in delaying disease progression, which includes a decline in exercise ability, worsening symptoms of PAH, or need for additional PAH medication. Common side effects observed in persons treated with Opsumit included low red blood cell count, common cold-like symptoms (nasopharyngitis), sore throat, bronchitis, headache, flu and urinary tract infection. Warnings, Precautions and Contraindications. The following warnings and precautions are listed. •Other ERAs cause hepatotoxicity and liver failure. Obtain baseline liver enzyme levels and monitor as clinically indicated. •Decreases in hemoglobin: Decreases in hemoglobin concentration and hematocrit have been reported. Measure the hemoglobin prior to initiation of treatment and repeat during treatment as clinically indicated. •Pulmonary edema in patients with pulmonary veno-occlusive

disease: If confirmed, discontinue treatment. •Decreased sperm count: Other ERAs have caused adverse effects on spermatogenesis. •A boxed warning advises that the drug should not be used during pregnancy, and that the drug is available only through the Opsumit REMS Program. The sole contraindication listed is pregnancy. Drug Interactions. Strong inducers of CYP3A4 (e.g., rifampin) significantly reduce macitentan exposure, thus concomitant use should be avoided. Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole) approximately doubles macitentan exposure. Many HIV drugs such as ritonavir are strong inhibitors of CYP3A4. Avoid concomitant use of Opsumit with strong CYP3A4 inhibitors. Administration, Dosing, and Counseling. The recommended dosage is 10 mg once daily orally. Doses higher than 10 mg once daily have not been studied in patients with PAH and are not recommended. Opsumit tablets contain 10 mg of macitentan. Specific points for counseling are summarized in Table 7.

Patient Education

In general, patients should be counseled that PH is a complex disease and markedly different than systemic hypertension. Regardless of its cause, serious PH almost always indicates significant systemic disease that requires ongoing, closely coordinated medical care, and close attention to salt intake, fluid balance, and home weight monitoring. Patients with PH may need to self-administer medications that have complex instructions, self-monitor for adverse effects or progression of disease, and help ensure that concomitant health care issues do not compromise or adversely interact with their PH regimen. Patients should also be informed of available information and peer support opportunities. Of tremendous assistance to both

25


Table 5 New drugs for treatment of pulmonary hypertension Generic Name

Distributor

Indication

Dose

Dosage Form

Macitentan (Opsumit)

Actelion Pharmaceuticals US, Inc.

PAH* (WHO Group 1)

10 mg once daily

10 mg tablets

Riociguat (Adempas)

Bayer HealthCare Pharmaceuticals Inc.

PAH* (WHO Group 1); CTEPH± (WHO Group 4)

1 mg 0.5 mg, 1 mg, three 1.5 mg, 2 mg, times and 2.5 mg daily (range: 0.5 mg to 2.5 mg three times daily)

Medication Guide

Yes

Yes

*PAH – Pulmonary Arterial Hypertension ± CTEPH – Chronic Thromboembolic Pulmonary Hypertension

take the drug at a dose of 1.5 mg or 2.5 mg, or placebo, three times daily. After 12 weeks of treatment, the 6-minute walk distance in patients treated with Adempas improved by an average of 36 meters (about 118 feet) more than in patients treated with placebo. Common adverse effects observed in patients treated with Adempas included headache, dizziness, indigestion, tissue swelling, nausea, diarrhea, and vomiting. Warnings, Precautions and Contraindications. The following warnings and precautions are listed. •Symptomatic hypotension: Adempas reduces blood pressure. Consider dose reductions if the patient develops signs or symptoms of hypotension. •Bleeding: Serious hemorrhagic events can occur. Monitor patient for signs and symptoms. •Pulmonary edema in patients with pulmonary veno-occlusive disease: Discontinue treatment if confirmed. •A boxed warning advises that the drug should not be used during pregnancy, and that the drug is available only through a restricted distribution program. Three contraindications are listed: pregnancy, use with nitrates or NO donors in any form (e.g., amyl nitrite), and use with phosphodiesterase inhibitors (e.g.,

24

dipyridamole, theophylline, sildenafil, tadalafil, vardenafil). Drug Interactions. Noted specifically are strong CYP and Pglycoprotein/breast cancer resistance protein (P-gp/BCRP) inhibitors. For patients receiving strong CYP and P-gp/BCRP inhibitors (e.g., ketoconazole, itraconazole, ritonavir), consider a starting dose of 0.5 mg three times a day. Monitor for hypotension. Antacids such as aluminum- or magnesium hydroxide decrease riociguat absorption, so doses of antacids and riociguat should be separated by at least one hour. Administration, Dosing, and Counseling. Initiate treatment at 1 mg three times a day. For patients who may not tolerate the hypotensive effect, consider a starting dose of 0.5 mg three times a day. Dosage may be increased by 0.5 mg intervals of no sooner than two weeks as tolerated, to a maximum dose of 2.5 mg three times a day. If a dose is missed, continue with the next regularly scheduled dose. In the event that Adempas dosing is interrupted for three or more days, re-titrate the drug. Plasma concentrations are reduced 50 to 60 percent in smokers. Consider titrating to dosages higher than 2.5 mg three times a day if tolerated in patients who smoke to match exposure seen in non-smokers. A decrease in dosage

Table 6 Patient information for riociguat (Adempas)* Patients: •should read the Medication Guide carefully and talk with their pharmacist or physician if they have questions. •(females) should use emergency contraception in the event of unprotected sex or contraceptive failure. Females must sign an enrollment form to register in the Adempas REMS Program; males are not required to do so. •(pre-pubertal females) should report any changes in her reproductive status immediately to her prescriber. •should be aware of the potential risks/signs of coughing up blood caused by the drug, and must contact their physician right away if signs/ symptoms appear. •should be aware it is important to stick closely to the dosing, titration, and maintenance of Adempas. If a dose is missed, patients should continue with the next regularly scheduled dose. In event the drug is interrupted for three or more days, the dose should be re-titrated. •should report all current medicines and new medicines to their physician. •should not take antacids within one hour of taking Adempas. •should be aware Adempas can cause dizziness, which can affect the ability to drive and use machines. •should be aware they should not use Adempas for a condition other than for what it was prescribed, or give it to other people, even if their symptoms are the same. •should be aware that Adempas should be stored at room temperature between 59oF to 86oF (15oC to 30oC). *Summarized from the FDAapproved Medication Guide

may be required in patients who stop smoking. Adempas is available in tablets containing 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg of riociguat. Specific points for counseling are summarized in Table 6.

Macitentan (Opsumit)

Opsumit (OP-sum-it) is the second new drug approved during October, 2013 for treatment of PH.

The Georgia Pharmacy Journal

Table 7 Patient information for macitentan (Opsumit)* Patients: •should read the Medication Guide carefully and talk with their pharmacist or physician if they have questions. •(females) may experience fetal harm when Opsumit is used during pregnancy. Instruct females to use effective contraception and to contact her physician if she suspects she may be pregnant. Females must sign an enrollment form to register in the Opsumit REMS Program; males are not required to do so. •(pre-pubertal females) should report any changes in her reproductive status immediately to her prescriber. •should get hemoglobin levels tested as the physician recommends. •should be aware the drug may interfere with spermatogenesis. •should be aware of signs of hepatotoxicity, and contact their doctor if they have unexplained nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching. •should not split, crush, or chew Opsumit tablets. •should store Opsumit tablets at 20oC to 25oC (68oF to 77oF), with excursions permitted between 15oC and 30oC (59oF and 86oF) *Summarized from the FDAapproved Medication Guide.

Indications and Use. The new drug is an ERA indicated for treatment of PAH (WHO Group 1) to delay disease progression. During clinical trials, disease progression included: death, initiation of intravenous or subcutaneous prostanoids, or clinical worsening of PAH (decreased six-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). The new drug also reduced hospitalizations for PAH. Mechanism of Action. Endothelin (ET)-1 and its receptors (ETA and ETB) mediate a variety of deleterious effects, such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation. In

The Georgia Pharmacy Journal

disease conditions such as PAH, the local ET system is upregulated and is involved in vascular hypertrophy and in organ damage. Macitentan is an ERA with high lipophilicity that prevents the binding of ET-1 to both ETA and ETB receptors. The dual ERA was developed by modifying the structure of bosentan (Tracleer) to increase efficacy and safety. The new drug is characterized by sustained receptor binding and enhanced tissue penetration. Macitentan displays high affinity and sustained occupancy of the ET receptors in human pulmonary arterial smooth muscle cells. One of the metabolites of macitentan is also pharmacologically active at the ET receptors and is estimated to be about 20 percent as potent as the parent drug in vitro. Efficacy and Safety. Safety and effectiveness were established primarily in one long-term clinical trial where 742 participants were randomly assigned to take Opsumit or placebo. The average treatment duration was about two years. In the study, Opsumit was effective in delaying disease progression, which includes a decline in exercise ability, worsening symptoms of PAH, or need for additional PAH medication. Common side effects observed in persons treated with Opsumit included low red blood cell count, common cold-like symptoms (nasopharyngitis), sore throat, bronchitis, headache, flu and urinary tract infection. Warnings, Precautions and Contraindications. The following warnings and precautions are listed. •Other ERAs cause hepatotoxicity and liver failure. Obtain baseline liver enzyme levels and monitor as clinically indicated. •Decreases in hemoglobin: Decreases in hemoglobin concentration and hematocrit have been reported. Measure the hemoglobin prior to initiation of treatment and repeat during treatment as clinically indicated. •Pulmonary edema in patients with pulmonary veno-occlusive

disease: If confirmed, discontinue treatment. •Decreased sperm count: Other ERAs have caused adverse effects on spermatogenesis. •A boxed warning advises that the drug should not be used during pregnancy, and that the drug is available only through the Opsumit REMS Program. The sole contraindication listed is pregnancy. Drug Interactions. Strong inducers of CYP3A4 (e.g., rifampin) significantly reduce macitentan exposure, thus concomitant use should be avoided. Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole) approximately doubles macitentan exposure. Many HIV drugs such as ritonavir are strong inhibitors of CYP3A4. Avoid concomitant use of Opsumit with strong CYP3A4 inhibitors. Administration, Dosing, and Counseling. The recommended dosage is 10 mg once daily orally. Doses higher than 10 mg once daily have not been studied in patients with PAH and are not recommended. Opsumit tablets contain 10 mg of macitentan. Specific points for counseling are summarized in Table 7.

Patient Education

In general, patients should be counseled that PH is a complex disease and markedly different than systemic hypertension. Regardless of its cause, serious PH almost always indicates significant systemic disease that requires ongoing, closely coordinated medical care, and close attention to salt intake, fluid balance, and home weight monitoring. Patients with PH may need to self-administer medications that have complex instructions, self-monitor for adverse effects or progression of disease, and help ensure that concomitant health care issues do not compromise or adversely interact with their PH regimen. Patients should also be informed of available information and peer support opportunities. Of tremendous assistance to both

25


patients and pharmacists is information provided by the Pulmonary Hypertension Association (www. phassociation.org). This site also includes advice for newly diagnosed patients.

Overview and Summary

PH is a relatively rare disease even though its etiological considerations are common. The disease is caused by a variety of etiologies characterized by pulmonary vasculopathy with endothelial dysfunction, cellular proliferation, and elevated pulmonary vascular resistance. Over the previous two decades there have been profound advancements in PH targeted treatments, resulting in symptom improvement, slowed disease progression, and improved survival. Two recently approved drugs have been added to the treatment armamentarium. Overall, further advancements are needed to prolong life expectancy and improve quality of life in these patients.

continuing education quiz

The author, the Ohio Pharmacists Foundation and the Ohio Pharmacists Association disclaim any liability to you or your patients resulting from reliance solely upon the information contained herein. Bibliography for additional reading and inquiry is available upon request. This lesson is a knowledge-based CE activity and is targeted to pharmacists in all practice settings.

1. Median survival time following diagnosis in persons with untreated pulmonary hypertension is: a. 1.5 years. c. 2.8 years. b. 2.0 years. d. 3.2 years.

Email_______________________________________________

4. Prostacyclin is also known as prostaglandin: a. E1. c. I1. b. E2. d. I2.

Release date: 4-15-14 Expiration date: 4-15-17

CE Hours: 1.5 (0.15 CEU)

5. A drug from the pharmacologic class of compounds considered to be the cornerstone of therapy for pulmonary hypertension is: a. bosetan. c. tadalafil. b. epoprostenol. d. ambrisentan.

The Ohio Pharmacists Foundation Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Name________________________________________________ Address_____________________________________________

3. The majority of drug development in pulmonary hypertension has been focused on patients in which of the following WHO groups? a. 1 c. 5 b. 3 d. 7

Program 0129-0000-14-004-H01-P

Program 0129-0000-14-004-H01-P 0.15 CEU

Advances in the Treatment of Pulmonary Hypertension: Focus on Adempas and Opsumit

2. The World Health Organization (WHO) recognizes how many categories of pulmonary hypertension? a. 1 c. 5 b. 3 d. 7

Please turn to Correspondence Course Quiz on page 23.

Please print.

6. Which of the following drugs is responsible for the degradation of cyclic guanosine monophosphate (cGMP) in treating pulmonary hypertension? a. Ventavis c. Tracleer b. Remodulin d. Revatio

City, State, Zip______________________________________

NABP e-Profile ID____________Birthdate_________

(MMDD)

Return quiz and payment (check or money order) to Correspondence Course, OPA, 2674 Federated Blvd, Columbus, OH 43235-4990

8. The product approved for treating patients with chronic thromboembolic pulmonary hypertension is: a. Adempas. c. Opsumit. b. Adcirca. d. Flolan. 9. All of the following are contraindications to use of riociguat EXCEPT: a. pregnancy. b. decreased hemoglobin. c. use with nitrates. d. use with phosphodiesterase inhibitors. 10. Patients taking Adempas should be advised to avoid taking which of the following drugs within one hour of Adempas? a. Decongestants c. Antihistamines b. Cathartics d. Antacids 11. Plasma concentrations of riociguat may be reduced by how much in smokers? a. 20 to 30 percent c. 40 to 50 percent b. 30 to 40 percent d. 50 to 60 percent

7. All of the following are goals of therapy in treating pulmonary hypertension EXCEPT to: a. prevent advancement of the disease. b. decrease activity levels. c. improve quality of life. d. decrease hospital admissions.

12. Opsumit is classified as a/an: a. endothelin receptor antagonist. b. prostacyclin derivative. c. phosphodiesterase-5 inhibitor. d. janus kinase inhibitor.

Completely fill in the lettered box corresponding to your answer.

13. Macitentan was developed by modifying the chemical structure of: a. bosentan. c. treprostinil. b. ambrisentan. d. tadalafil.

1. 2. 3. 4. 5.

[a] [a] [a] [a] [a]

[b] [b] [b] [b] [b]

[c] [c] [c] [c] [c]

[d] 6. [a] [d] 7. [a] [d] 8. [a] [d] 9. [a] [d] 10. [a]

[b] [b] [b] [b] [b]

[c] [c] [c] [c] [c]

[d] [d] [d] [d] [d]

11. [a] 12. [a] 13. [a] 14. [a] 15. [a]

[b] [b] [b] [b] [b]

[c] [c] [c] [c] [c]

[d] [d] [d] [d] [d]

 I am enclosing $5 for this month’s quiz made payable to: Ohio Pharmacists Association. 1. Rate this lesson: (Excellent) 5 4 3 2 1 (Poor) 2. Did it meet each of its objectives?  yes  no If no, list any unmet_______________________________ 3. Was the content balanced and without commercial bias?  yes  no 4. Did the program meet your educational/practice needs?  yes  no 5. How long did it take you to read this lesson and complete the quiz? ________________ 6. Comments/future topics welcome.

14. All of the following are precautions/warnings for use of macitentan EXCEPT: a. decreased hemoglobin. c. symptomatic hypotension. b. pulmonary edema. d. decreased sperm count. 15. Advice for persons taking Opsumit includes: a. avoid driving or operating heavy machinery. b. keep unopened bottles of Opsumit refrigerated. c. do not crush or chew tablets. d. avoid sunlight or exposure to UV bulbs.

To receive CE credit, your quiz must be received no later than April 15, 2017. A passing grade of 80% must be attained. CE credit for successfully completed quizzes will be uploaded to the CPE Monitor. CE statements of credit will not be mailed, but can be printed from the CPE Monitor website. Send inquiries to opa@ohiopharmacists.org.

april 2014

26

The Georgia Pharmacy Journal

The Georgia Pharmacy Journal

27


patients and pharmacists is information provided by the Pulmonary Hypertension Association (www. phassociation.org). This site also includes advice for newly diagnosed patients.

Overview and Summary

PH is a relatively rare disease even though its etiological considerations are common. The disease is caused by a variety of etiologies characterized by pulmonary vasculopathy with endothelial dysfunction, cellular proliferation, and elevated pulmonary vascular resistance. Over the previous two decades there have been profound advancements in PH targeted treatments, resulting in symptom improvement, slowed disease progression, and improved survival. Two recently approved drugs have been added to the treatment armamentarium. Overall, further advancements are needed to prolong life expectancy and improve quality of life in these patients.

continuing education quiz

The author, the Ohio Pharmacists Foundation and the Ohio Pharmacists Association disclaim any liability to you or your patients resulting from reliance solely upon the information contained herein. Bibliography for additional reading and inquiry is available upon request. This lesson is a knowledge-based CE activity and is targeted to pharmacists in all practice settings.

1. Median survival time following diagnosis in persons with untreated pulmonary hypertension is: a. 1.5 years. c. 2.8 years. b. 2.0 years. d. 3.2 years.

Email_______________________________________________

4. Prostacyclin is also known as prostaglandin: a. E1. c. I1. b. E2. d. I2.

Release date: 4-15-14 Expiration date: 4-15-17

CE Hours: 1.5 (0.15 CEU)

5. A drug from the pharmacologic class of compounds considered to be the cornerstone of therapy for pulmonary hypertension is: a. bosetan. c. tadalafil. b. epoprostenol. d. ambrisentan.

The Ohio Pharmacists Foundation Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Name________________________________________________ Address_____________________________________________

3. The majority of drug development in pulmonary hypertension has been focused on patients in which of the following WHO groups? a. 1 c. 5 b. 3 d. 7

Program 0129-0000-14-004-H01-P

Program 0129-0000-14-004-H01-P 0.15 CEU

Advances in the Treatment of Pulmonary Hypertension: Focus on Adempas and Opsumit

2. The World Health Organization (WHO) recognizes how many categories of pulmonary hypertension? a. 1 c. 5 b. 3 d. 7

Please turn to Correspondence Course Quiz on page 23.

Please print.

6. Which of the following drugs is responsible for the degradation of cyclic guanosine monophosphate (cGMP) in treating pulmonary hypertension? a. Ventavis c. Tracleer b. Remodulin d. Revatio

City, State, Zip______________________________________

NABP e-Profile ID____________Birthdate_________

(MMDD)

Return quiz and payment (check or money order) to Correspondence Course, OPA, 2674 Federated Blvd, Columbus, OH 43235-4990

8. The product approved for treating patients with chronic thromboembolic pulmonary hypertension is: a. Adempas. c. Opsumit. b. Adcirca. d. Flolan. 9. All of the following are contraindications to use of riociguat EXCEPT: a. pregnancy. b. decreased hemoglobin. c. use with nitrates. d. use with phosphodiesterase inhibitors. 10. Patients taking Adempas should be advised to avoid taking which of the following drugs within one hour of Adempas? a. Decongestants c. Antihistamines b. Cathartics d. Antacids 11. Plasma concentrations of riociguat may be reduced by how much in smokers? a. 20 to 30 percent c. 40 to 50 percent b. 30 to 40 percent d. 50 to 60 percent

7. All of the following are goals of therapy in treating pulmonary hypertension EXCEPT to: a. prevent advancement of the disease. b. decrease activity levels. c. improve quality of life. d. decrease hospital admissions.

12. Opsumit is classified as a/an: a. endothelin receptor antagonist. b. prostacyclin derivative. c. phosphodiesterase-5 inhibitor. d. janus kinase inhibitor.

Completely fill in the lettered box corresponding to your answer.

13. Macitentan was developed by modifying the chemical structure of: a. bosentan. c. treprostinil. b. ambrisentan. d. tadalafil.

1. 2. 3. 4. 5.

[a] [a] [a] [a] [a]

[b] [b] [b] [b] [b]

[c] [c] [c] [c] [c]

[d] 6. [a] [d] 7. [a] [d] 8. [a] [d] 9. [a] [d] 10. [a]

[b] [b] [b] [b] [b]

[c] [c] [c] [c] [c]

[d] [d] [d] [d] [d]

11. [a] 12. [a] 13. [a] 14. [a] 15. [a]

[b] [b] [b] [b] [b]

[c] [c] [c] [c] [c]

[d] [d] [d] [d] [d]

 I am enclosing $5 for this month’s quiz made payable to: Ohio Pharmacists Association. 1. Rate this lesson: (Excellent) 5 4 3 2 1 (Poor) 2. Did it meet each of its objectives?  yes  no If no, list any unmet_______________________________ 3. Was the content balanced and without commercial bias?  yes  no 4. Did the program meet your educational/practice needs?  yes  no 5. How long did it take you to read this lesson and complete the quiz? ________________ 6. Comments/future topics welcome.

14. All of the following are precautions/warnings for use of macitentan EXCEPT: a. decreased hemoglobin. c. symptomatic hypotension. b. pulmonary edema. d. decreased sperm count. 15. Advice for persons taking Opsumit includes: a. avoid driving or operating heavy machinery. b. keep unopened bottles of Opsumit refrigerated. c. do not crush or chew tablets. d. avoid sunlight or exposure to UV bulbs.

To receive CE credit, your quiz must be received no later than April 15, 2017. A passing grade of 80% must be attained. CE credit for successfully completed quizzes will be uploaded to the CPE Monitor. CE statements of credit will not be mailed, but can be printed from the CPE Monitor website. Send inquiries to opa@ohiopharmacists.org.

april 2014

26

The Georgia Pharmacy Journal

The Georgia Pharmacy Journal

27


Need to update Board of Directors? GET THE APP! THE GEORGIA PHARMACY ASSOCIATION

2013-2014

Board of Directors The GPhA Mobile App.

Name

Position

Robert M. Hatton

Chair of the Board

Pamala S. Marquess

President

Robert B. Moody President-Elect Thomas H. Whitworth

First Vice President

Lance P. Boles

Second Vice President

Liza Chapman

State At Large

Terry Forshee

State At Large

David Graves

State At Large

Joshua D. Kinsey

State At Large

Eddie Madden

State At Large

Laird Miller

State At Large

Chris Thurmond

State At Large

Krista Stone

1st Region President

Ed S. Dozier

2nd Region President

Renee D. Adamson

3rd Region President

Nicholas O. Bland

4th Region President

Shelby Biagi

5th Region President

Sherri S. Moody

6th Region President

Renew your membership - join the Association.

Tyler Mayotte

7th Region President

Michael Lewis

8th Region President

Receive Association reminders and updates.

Amanda Westbrooks

9th Region President

Flynn Warren

10th Region President

Kalen Manasco

11th Region President

Ken Von Eiland

12th Region President

Ted Hunt

ACP Chair

Sharon B. Zerillo

AEP Chair

John Drew

AHP Chair

Drew Miller

AIP Chair

Michelle Hunt

APT Chair

Leah Stowers

ASA Chair

John T. Sherrer

Foundation Chair

Al McConnell

Board of Pharmacy Chair

Megan Freeman

GSHP President

Amy C. Grimsley

Mercer Faculty Representative

Rusty Fetterman

South Faculty Representative

Lindsey Welch

UGA Faculty Representative

Contact Association Staff. Share this App with a friend. Association and Industry News. Check out Association events and register.

Connect with the GPhA on facebook. Learn about GPhA services. Connect with friends and associates. Important Advocacy links.

We’re going mobile, leveraging mobile technology to meet member’s communication, education, advocacy, and engagement needs. Available anywhere and anytime you need it.

Search gpha using the App Store or Google Play. Download and You’ve Got the App!

IT’S FREE!

Android

Apple

Tyler Bryant

Thanks ... ...to the many members who support the Georgia Pharmacy Association’s Academy of Independent Pharmacy. We pledge to continue to defend and protect the profession to the best of our ability and we pledge to continue to fight for the economic viability of Independent Pharmacy. AIP Mission Statement: To advance the concept of pharmacy care. To ensure the economic viability and security of Independent Pharmacy; To provide a forum for Independent Pharmacy to exchange information and develop strategies, goals and objectives; To address the unique business and professional issues of independent pharmacies; To develop and implement marketing opportunities for members of the Academy with emphasis on the third party prescription drug program/benefit market; To provide educational programs designed to enhance the managerial skills of Independent Pharmacy Owners and Managers; and, To establish and implement programs and services designed to assist Independent Pharmacy Owners and Managers.

ASP, Mercer University

Tiffany Galloway

ASP, South University

Jessica Kupstas

ASP, UGA

Jim Bracewell

Executive Vice President

The Georgia Pharmacy Journal

THE GEORGIA PHARMACY ASSOCIATION 50 Lenox Pointe, NE, Atlanta, GA 30324 | tf: 888.871.5590 | ph: 404.231.5074 | f: 404.237.8435 | www.gpha.org


Need to update Board of Directors? GET THE APP! THE GEORGIA PHARMACY ASSOCIATION

2013-2014

Board of Directors The GPhA Mobile App.

Name

Position

Robert M. Hatton

Chair of the Board

Pamala S. Marquess

President

Robert B. Moody President-Elect Thomas H. Whitworth

First Vice President

Lance P. Boles

Second Vice President

Liza Chapman

State At Large

Terry Forshee

State At Large

David Graves

State At Large

Joshua D. Kinsey

State At Large

Eddie Madden

State At Large

Laird Miller

State At Large

Chris Thurmond

State At Large

Krista Stone

1st Region President

Ed S. Dozier

2nd Region President

Renee D. Adamson

3rd Region President

Nicholas O. Bland

4th Region President

Shelby Biagi

5th Region President

Sherri S. Moody

6th Region President

Renew your membership - join the Association.

Tyler Mayotte

7th Region President

Michael Lewis

8th Region President

Receive Association reminders and updates.

Amanda Westbrooks

9th Region President

Flynn Warren

10th Region President

Kalen Manasco

11th Region President

Ken Von Eiland

12th Region President

Ted Hunt

ACP Chair

Sharon B. Zerillo

AEP Chair

John Drew

AHP Chair

Drew Miller

AIP Chair

Michelle Hunt

APT Chair

Leah Stowers

ASA Chair

John T. Sherrer

Foundation Chair

Al McConnell

Board of Pharmacy Chair

Megan Freeman

GSHP President

Amy C. Grimsley

Mercer Faculty Representative

Rusty Fetterman

South Faculty Representative

Lindsey Welch

UGA Faculty Representative

Contact Association Staff. Share this App with a friend. Association and Industry News. Check out Association events and register.

Connect with the GPhA on facebook. Learn about GPhA services. Connect with friends and associates. Important Advocacy links.

We’re going mobile, leveraging mobile technology to meet member’s communication, education, advocacy, and engagement needs. Available anywhere and anytime you need it.

Search gpha using the App Store or Google Play. Download and You’ve Got the App!

IT’S FREE!

Android

Apple

Tyler Bryant

Thanks ... ...to the many members who support the Georgia Pharmacy Association’s Academy of Independent Pharmacy. We pledge to continue to defend and protect the profession to the best of our ability and we pledge to continue to fight for the economic viability of Independent Pharmacy. AIP Mission Statement: To advance the concept of pharmacy care. To ensure the economic viability and security of Independent Pharmacy; To provide a forum for Independent Pharmacy to exchange information and develop strategies, goals and objectives; To address the unique business and professional issues of independent pharmacies; To develop and implement marketing opportunities for members of the Academy with emphasis on the third party prescription drug program/benefit market; To provide educational programs designed to enhance the managerial skills of Independent Pharmacy Owners and Managers; and, To establish and implement programs and services designed to assist Independent Pharmacy Owners and Managers.

ASP, Mercer University

Tiffany Galloway

ASP, South University

Jessica Kupstas

ASP, UGA

Jim Bracewell

Executive Vice President

The Georgia Pharmacy Journal

THE GEORGIA PHARMACY ASSOCIATION 50 Lenox Pointe, NE, Atlanta, GA 30324 | tf: 888.871.5590 | ph: 404.231.5074 | f: 404.237.8435 | www.gpha.org


THE GEORGIA PHARMACY ASSOCIATION

50 Lenox Pointe, NE Atlanta, GA 30324

139 th gph A c on v en tion Ju n e 26 -29, 2014 Wy n dh a m Bay Poi n t R e sort - Pa na m a Cit y Be ach, F L

As healthcare changes, so do job responsibilities and career tracks. The Georgia Pharmacy Association is your development partner as you address your future in pharmacy. Professional networking, skills training and continuing education are key benefits of your GPhA membership. Plan to attend this year’s Convention and take advantage of all the educational and networking opportunities available. Whether you’re a seasoned professional or a first year student, there’s something for you at the GPhA Convention. We’re looking forward to seeing you there.

Go to www.gpha.org and click on the Convention Banner or scan the code below.

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