A Legal Look at Telepharmacy Adam Chesler, PharmD Disclosures Cardinal Health has a commercial interest in telepharmacy. Target Audience: Pharmacists and Pharmacy Technicians ACPE#: 0202-0000-17-106-L03-P/T Activity Type: Knowledge-based The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Learning Objectives 1. Explain why telepharmacy started and how it has evolved with technology. 2. List the different types of telepharmacy and how its use is improving patient care. 3. Describe the telepharmacy regulatory environment around the United States and what states are doing with rules. 1. Which of these is not a type of telepharmacy? A. Remote Order Entry B. Remote Dispensing C. Remote Consultation D. Internet Pharmacy 1
2. Telepharmacy is becoming less prevalent in America A. True B. False C. Answering this question is a slippery slope D. I can neither confirm or deny this 3. Which of the following healthcare providers has the most patient contact? A. Pharmacist B. Primary Care Physician C. Dentist D. Veterinarian 4. Available data from the implementation of telepharmacy in North Dakota showed the creation of new jobs. A. Yes, it created over 80 new jobs B. Yes, but all the jobs went to China C. No, no new jobs were created D. No, it actually took away jobs 5. Which group would be considered to have access issues? A. Seniors B. Low vehicle ownership C. Both D. Neither 6. Which of the following are ways to increase pharmacist presence? A. Telepharmacy in warfarin clinics B. Telepharmacy to allow HIV medications at discharge C. Telepharmacy to allow overnight coverage at rural hospitals/clinics D. All of the above Why telepharmacy? 1. Utilize technology to improve patient adherence 2. Enable access to a pharmacist in rural communities 3. Increase pharmacist outreach in urban areas 2
A Little Background The four types of telepharmacy Remote Order Entry Review Retail Telepharmacy INPATIENT IV Admixture Remote Counseling OUTPATIENT Need for Alternative Delivery Telepharmacy Timeline Mar 2003 - Dec 2013 924 independent rural pharmacies closed 490 rural communities lost their only pharmacy Australia North Dakota Minnesota 2003 2010 2012 1942 2002 2007 Alaska U.S. Navy Source: Update: Independently Owned Pharmacy Closures in Rural America, 2003-2013; RUPRI Center for Rural Health Policy Analysis, Rural Policy Brief June 2014; Fred Ullrich, BA; Keith J. Mueller, PhD North Dakota Telepharmacy Project North Dakota Telepharmacy Project STUDY FINDINGS Dispensing Errors ~1.7% National Average <1% North Dakota Study 53 28 retail hospitals For more info: www.ndsu.edu/telepharmacy Source: The North Dakota Experience: Achieving High-Performance Health Care Through Rural Innovation And Cooperation. May 2008 Source: The North Dakota Experience: Achieving High-Performance Health Care Through Rural Innovation And Cooperation. May 2008 3
Telepharmacy language, 2008 Telepharmacy language, 2016 Source: Telepharmacy project expands across country; 9/12/2008; Dave Kolpack, Associated Press Source: Quarles & Brady LLP analysis & report, July 2016 Why telepharmacy? Telepharmacy language, 2016 1. Utilize technology to improve patient adherence 2. Enable access to a pharmacist in rural communities 3. Increase pharmacist outreach in urban areas 187 million 14.7% 13% $290 billion Americans take 1+ prescriptions healthcare expenses directly related to nonadherence avoidable costs Sources: Osterberg, L., Blaschke, T. (2005). Adherence to medication. N Engl J Med, 353(5), 487-497; Thinking Outside the Pillbox, A System-wide Approach to Improving Patient Medication Adherence for Chronic Disease; A NEHI Research Brief August 2009 The Leaky Bucket Annual patient visits 35 100 50-70 48-66 25-30 15-20 4 9 new prescriptions arrive at a pharmacy picked up by the patient taken properly refilled as prescribed Primary care physician Other healthcare providers Pharmacist Source: IMS Health Data, March 2011 Source: Pharmacists as Influencers of Patient Adherence, August 21, 2014, Joseph Moose, PharmD, and Ashley Branham, PharmD, BCACP 4
Patients desire convenience 95% Why telepharmacy? 1. Utilize technology to improve patient adherence 2. Enable access to a pharmacist in rural communities 3. Increase pharmacist outreach in urban areas patients filled initial prescriptions when offered at doctor s office Source: New Prescription Medication Gaps: A Comprehensive Measure of Adherence to New Prescriptions; Harvard Business Review Vol 44 Num 5 Oct 2009. Definition of Rural Definition of Rural Rural encompasses all population, housing, and territory not included within an urban area. 19.3% 77% of total population lives in rural areas rural counties considered health professional shortage areas Source: The Crisis in Rural Primary Care; WWAMI Rural Health Research Center, Policy Brief April 2009 2010 Census Urban and Rural Classification and Urban Area Criteria, https://www.census.gov/geo/reference/ua/urban-rural-2010.html Telepharmacy helps create a new patient-pharmacist relationship that wasn t possible before. Angela Falk, PharmD NuCara Pharmacy, Zearing IA 5
Community telepharmacy in Iowa NuCara Pharmacy, State Center IA NuCara Pharmacy, State Center IA BEFORE Economic impact of telepharmacy NORTH DAKOTA ILLINOIS AFTER $26.5million economic development 80-100 new jobs created $640k annual economic impact Source: North Dakota Telepharmacy Project https://www.ndsu.edu/telepharmacy/; Rural Economic Technical Assistance Center (RETAC) in Macomb, IL; Economic impacts of a pharmacy for Deiterich, Illinois, June 2015 Why telepharmacy? Pharmacy Deserts in Chicago 1. Utilize technology to improve patient adherence 2. Enable access to a pharmacist in rural communities 3. Increase pharmacist outreach in urban areas DISTANCE 1 mile POPULATION 1 million Source: Source: Pharmacy Deserts Are Prevalent In Chicago s Predominantly Minority Communities, Raising Medication Access Concerns, Dima M. Qato,, Martha L. Daviglus, Jocelyn Wilder, Todd Lee, Danya Qato and Bruce Lambert. 6
Prescriptions at the point-of-care Readmissions influenced by access RURAL URBAN 75% 15.3% 14.7% patients would prefer to fill prescriptions where they see their doctor* * if given the choice Rate of hospital readmissions for patients Source: Patient Attitudes toward Point-of-Care Medication Dispensing in a Primary Care Office Setting. July 19-22, 2007 by Opinion Research Corporation on behalf of Purkinje. www.purkinje.com. Source: Lack of pharmacy access sends some patients back to the hospital; Oregon State University and Oregon Health & Science University, August 2016 + Better Education Better Access Skywalk Pharmacy, Delafield WI Better Outcomes Skywalk Pharmacy, Delafield WI In-clinic pharmacy in Madison, WI 7
In-clinic pharmacy in Chicago, IL Common Questions What are some of the most common questions and concerns with telepharmacy? Software solutions Advantages Live pharmacist interaction Constant updates Low initial costs Better education Disadvantages Can be limited hours Live internet connection Automated solutions Advantages Can be available 24 hours No on-site staff needed Disadvantages Cost-prohibitive Limited formulary Mechanical failure Complicated Telepharmacy Workflow Endless opportunities A B 1 2 New prescription arrives at Pharmacy A Technician A fills, taking images of the process Workload balancing Hospitals Tech RPh Tech 3 4 Pharmacist B reviews images to verify fill is accurate Patient picks up Rx at Pharmacy A and Pharmacist B counsels Pharmacy deserts Accessible specialists 8
FAQ Fill Accuracy Safety (staff & location) Diversion Internet outage Telepharmacy regulations, 2016 Source: Quarles & Brady LLP analysis & report, July 2016 Regulations are fragmented Different for each type of telepharmacy Vary widely by state Practice setting Verification site location Urban allowances States that have telepharmacy language can benefit from aligning their rules NABP currently has a task force to create model language Typical regulations Pharmacy technician certification Hours and/or years of experience Limits on number of remote sites or technicians Special rules around Controls Mileage restrictions Security requirements Technological requirements Signage in the telepharmacy location Telepharmacy regulation considerations Need is increasing every year Physician Dispensing Mail-Order Successful programs already in place Consider the present as well as the future Get ahead of the technology and legislators Don t include technology requirements Steps to implementing regulations 1. Look for statutory authority If no statutory authority, must engage legislature 2. Have Board Rules Committee draft rules 3. Board notices rules to the public 4. Public comment period 5. Administrative Rules Review process & approval 6. Implementation 9
Tips/tricks to drafting regulations 1. Look into what other states have for regulation 2. Visit a retail telepharmacy location which is in operation 3. Understand the landscape in your state 4. Ensure statutes leave room for administrative rules Why telepharmacy? 1. Utilize technology to improve patient adherence 2. Enable access to a pharmacist in rural communities 3. Increase pharmacist outreach in urban areas 1. Which of these is not a type of telepharmacy? A. Remote Order Entry B. Remote Dispensing C. Remote Consultation D. Internet Pharmacy 2. Telepharmacy is becoming less prevalent in America A. True B. False C. Answering this question is a slippery slope D. I can neither confirm or deny this 3. Which of the following healthcare providers has the most patient contact? A. Pharmacist B. Primary Care Physician C. Dentist D. Veterinarian 4. Available data from the implementation of telepharmacy in North Dakota showed the creation of new jobs. A. Yes, it created over 80 new jobs B. Yes, but all the jobs went to China C. No, no new jobs were created D. No, it actually took away jobs 10
5. Which group would be considered to have access issues? A. Seniors B. Low vehicle ownership C. Both D. Neither 6. Which of the following are ways to increase pharmacist presence? A. Telepharmacy in warfarin clinics B. Telepharmacy to allow HIV medications at discharge C. Telepharmacy to allow overnight coverage at rural hospitals/clinics D. All of the above 11