01.21.16 Pharmacy – Meeting Minutes

BOARD OF PHARMACY Professional & Vocational Licensing Division Department of Commerce and Consumer Affairs State of Hawaii

MINUTES OF MEETING

Date: Thursday, January 21, 2016

Time: 9:00 a.m.

Place: Queen Liliuokalani Conference Room 335 Merchant Street, First Floor King Kalakaua Building Honolulu, HI. 96813

Members Present: Kerri Okamura, RPh, Chair, Pharmacist Mary Jo Keefe, RPh, Pharmacist Marcella Chock, PharmD., Pharmacist Carolyn Ma, PharmD., BCOP, Pharmacist

Members Excused: Garrett Lau, RPh,Vice Chair, Pharmacist

Staff Present: Lee Ann Teshima, Executive Officer ("EO") Shari Wong, Deputy Attorney General (“DAG”) Lisa Kalani, Secretary

Guests: Paul Smith, Walgreens Albert Lau, Kaiser Permanente Greg Edwards, Department of Health, Food and Drug Branch Fred Cruz, CVS Caremark Richard S. Mejia, Times Farbod Melaned, Roxsan Pharmacy Tanaz Kohan, Roxsan Pharmacy Jenna Ryan, SDSU McKenzie Bruer, SDSU Intern Patrick Uyemoto, Times Kevin Flores, Daniel K. Inouye, College of Pharmacy Mark Johnston, Long’s Corporate Lauren Berta, CVS Joe Parriott, Walmart Stacy Pi, Kaiser Permanente Tiffany Yajima, Ashford & Wriston Heather Lusk, Chow Project Glen Wasserman, Dept. of Health Catalina Cross, Times Peter Whiticar, Dept. of Health

Board of Pharmacy Minutes of the January 21, 2016 Meeting Page 2

Call to Order: The agenda for this meeting was filed with the Office of the Lieutenant Governor, as required by section 92-7(b), Hawaii Revised Statutes ("HRS").

There being a quorum present, the Chair called the meeting to order at 9:02 a.m. and excused the Vice Chair from today’s meeting.

Chair’s Report: Announcements and Introductions

The Chair asked the audience to introduce themselves.

Additions/Additional Distribution to Agenda

The Chair announced the following additional distribution:

Additional Distribution

3. Executive Officer’s Report d. 2016 Legislature 1) Nalaxone bill

4. Correspondence a. Medicaid Requirement – Tamper Resistant Rx Pad?

Approval of the Previous Minutes – November 19, 2015

The Chair called for a motion in regards to the minutes of the November 19, 2015 meeting.

There being no discussion, upon a motion by Dr. Ma, seconded by Dr. Chock, it was voted on and unanimously carried to approve the minutes for the November 19, 2015 meeting as circulated.

Executive Officer’s HAR Title 16, Chapter 95 – Status Report Report: The EO reported that the two proposed amendments to Chapter 95 are moving along. A request to hold a public hearing was recently sent to the Governor. We are hoping to hold the public hearing in conjunction with the March meeting.

Conferences/Seminars/Meetings

The EO reported that she attended the NABP Interactive Compliance Officer and Legal Counsel Forum, December 1-2, 2015, Illinois with RICO Investigator Kristen Kimoto. The meeting was very informational. There were only two EO’s in attendance, everyone else was compliance officers or inspectors. She will provide the Board with a written report.

Board of Pharmacy Minutes of the January 21, 2016 Meeting Page 3

2016 Psychopharmacology Conference, February 3-5, 2016, providers: UH @ Hilo Daniel K. Inouye College of Pharmacy and UH @ Manoa John A. Burns School of Medicine and the Hawaii Association of Professional Nurses

The EO reported the final lineup of speakers for day 3 of the Conference has been announced as Day 3: Medical Marijuana Friday, February 5th.

 Keynote Speaker: Kevin P. Hill, MD, MHS – Topic: Medical Marijuana: What Health Care Professionals Need to Know  Guest Speaker, David M. Louie, JD – Topic: Legal Considerations  Guest Speaker, Christopher D. Flanders, DO – Topic: Medical Marijuana – State and National Policy.

Renewals – Status Report

The EO reported the renewal period ended 12/31/15. The following are statistics as of January 20, 2016:

 Pharmacist – 2,544 renewed out of 2,719 licenses  Pharmacy – 276 renewed out of 294 licenses  Pharmacy Miscellaneous Permit – 596 renewed out of 695 licenses  Pharmacy Wholesale Distributor – 52 renewed out of 67 licenses

The EO also mentioned that the 2015 Gallop Polls have come out, and pharmacist are rated as the 2nd most honest and ethical people in the profession. Nurses are rated 1st and Doctors were rated 3rd.

2016 Legislature

Nalaxone Bill

The EO deferred to Peter Whiticar from the Dept. of Health.

Mr. Whiticar stated regarding SB2046, this is a bill that was leftover from last year. In Hawaii as well as across the country there are many unintended deaths as a result of opioid overdose. A very reliable way to prevent death from opioid overdose is through the use of Naloxone. The FDA has recently approved a nasal spray as well so it will be much easier to administer to patients. Unfortunately however Naloxone is not very readily available. The idea throughout the country in legislation is to make Naloxone available not only to people that use opioids legally or illegally, but also to friends, family or any other persons who may assist opioid users when they are in distress. The other issue is making Naloxone available to organizations. The main change being looked at through a number of bills is the issuing of standing orders. This would come from a medical professional that already has prescribing authority. This would allow them to write prescriptions not only to people who use opioids but also to other individuals. Board of Pharmacy Minutes of the January 21, 2016 Meeting Page 4

More importantly it would allow the issuing of standing orders to all kinds of individuals, organizations, and wherever there is a risk of people overdosing from opioids. It will grant broad immunity for healthcare professionals, pharmacists, individuals, organizations, law enforcement and emergency responders if they are using Naloxone for the right purposes. The work cut out for pharmacists is coming up with protocol that will allow you to work with standing orders to dispense Naloxone to persons or organizations that are listed in the standing orders. There have been some discussion about training and education. What is recommended is the support for education and training but not mandating it. All they want to do is ensure that any possible barriers are removed for the implementation of this bill.

The EO stated regarding the section that talks about the Board coming up with protocols to dispense Naloxone without a prescription under standing orders, currently the Board does not have a definition for standing orders, and they require a patient specific prescription in order to dispense any prescription drug. I see in Virginia they have collaborative practice agreements that allow their pharmacists to dispense Naloxone, but I’m not sure if it requires them to have a patient specific prescription.

Mr. Mark Johnston from CVS Health and Long’s Corporate suggested a statewide protocol agreement where the Board of Pharmacy’s standards any pharmacist is able to use, where maybe there is one physician at the Department of Health that can sign off. He would actually go a step further, and say that there are several states that have prescriptive authority for pharmacists. Some states use different language, for example in California pharmacist can “furnish” medications. Other states use the words “order and dispense” instead of prescribe, but it is essentially the same thing.

Ms. Keefe stated she likes the idea of a physician at the Department of Health signing off rather than someone in the community. Regarding patient specific prescriptions, someone is going to come into the pharmacy, the prescription is not for him/her, what are the states doing about that?

Mr. Johnston stated that is an excellent question, and the easy answer is that is an insurance billing issue and we don’t deal with insurance billing issues. In Idaho, Medicaid came out and said that they were so concerned that they would pay for the prescription written in the patients’ names if it was anybody else that picked it up for them.

Ms. Keefe stated a third party payment may not be our issue, but then it becomes a public safety issue if you can’t get it, so payment would become an issue.

The Chair stated in the bill it talks about Medicaid coverage.

Dr. Chock asked if the Department of Health has information on the number of opioid overdose related deaths?

Board of Pharmacy Minutes of the January 21, 2016 Meeting Page 5

Mr. Glen Wasserman from the Department of Health stated it’s about 80 reported deaths per year.

Mr. Johnston stated there are 2 different topics we have not talked about today, but assuming there is a requirement that the label be in the name of the patient and if you are going to dispense it to the fire department or police department you are going to have change that to allow it to be dispensed to an entity if for Naloxone. The other thing is the issue of who can possess drugs in the absence of a prescription. Most healthcare professionals and police officers can possess it but we had to add citizens can possess Naloxone even if the prescription is not in their name.

Mr. Greg Edwards stated in the bill it addresses Chapter 328 in a very broad sense that the product would not be subject to Chapter 328 parts 1 through 5, which is very sweeping. You need to look at what you’re trying to specifically exclude out of Chapter 328.

Mr. Whiticar asked Mr. Edwards if he would work with him on these issues with Chapter 328.

Mr. Edwards replied yes.

The EO stated she is not a pharmacist, so if someone is not overdosing and takes Naloxone, what will happen to them?

Mr. Wasserman stated it’s safe, nothing would happen.

The EO asked if there is any chance of Naloxone becoming an over-the-counter (“OTC”) drug?

Ms. Heather Lusk from the Chow Project stated the FDA has had hearings about that, so there is talks about it becoming an OTC on a national level.

The DAG stated it would be good to have a definition of “protocol” in the bill and to differentiate that from a standing order.

The EO stated what she is understanding is that in order to implement this program you either come up with protocols that may or may not include a standing order, or you have a specific formulary for pharmacist in order to prescribe those specific drugs on that formulary.

The Chair stated if you’re trying to decrease barriers, prescriptive authority would probably be the best way.

Board of Pharmacy Minutes of the January 21, 2016 Meeting Page 6

The EO stated the whole purpose is to open it up and make Naloxone readily available. Now if you go down the route of prescriptive authority and you come up with these standards that everyone has to meet in order to have limited prescriptive authority, you will still be restricting the availability of the drug.

Dr. Chock asked the audience, understanding the need for Naloxone to be readily available, what would be the easiest way to implement and execute this if the language were to be put in legislation?

Mr. Joe Parriott from Walmart stated they have a standing order with a physician, and so all of the stores on the island use the same standing order. If that doctor would agree to add Naloxone, then it would just be a matter of programming.

Ms. Lusk stated her organization has funders that they can get monies from and through a physician standing order, through their license be able to order Naloxone as long as they have exemption from 328 that allows us to store Naloxone, then we distribute it through a best practice model that agencies like her own use.

Dr. Chock asked the other audience members if they use standing orders?

Ms. Lauren Berta from CVS Health stated that they do.

Dr. Ma stated she will check with her students if they can research from now until the next meeting on Naloxone and protocols in other states.

The EO stated there may also be a carryover Durable Medical Equipment (“DME”) bill from last year that the Board supported, although she has not seen it yet.

Correspondence: Medicaid Requirement – Tamper Resistant Rx Pad?

The Board reviewed information from a doctor’s office that received the following information from a pharmacy and wanted to know if it is a requirement: “All Medicaid prescriptions that are presented in-person at the pharmacy must be written on a tamper-resistant prescription pad. If, during auditing, a prescription is found that was not written on a tamper-resistant pad, that claim will be subject to chargeback”.

Dr. Chock stated the information is correct and is on Medicaid’s webpage.

The Chair stated she believes that reminders were sent out about this requirement to pharmacies, she is not sure if it was sent to providers.

Board of Pharmacy Minutes of the January 21, 2016 Meeting Page 7

Letter from the National Transportation Safety Board

The EO reported that in 2014 the National Transportation Safety Board (“NTSB”) sent a letter with their recommendations asking the Board to disseminate their recommendations. At the time, the Board did not move on their letter. The NTSB followed up last year, 2015 with another letter to all the states, including the Governor stating they have not heard anything back on their recommendations. The Board of Pharmacy, Board of Nursing, Medical Board and Dental Board are going to work together to come up with a consensus policy statement to be adopted by the respective Board’s and placed onto their respective webpages.

Applications: Ratification List

Upon a motion by Ms. Keefe, seconded by Dr. Chock, it was voted on and unanimously carried to approve the attached ratification lists.

Executive Session: At 10:11 a.m. upon a motion by Ms. Keefe, seconded by Dr. Ma, it was voted on and unanimously carried to move into Executive Session in accordance with HRS, 92-5(a)(4), “To consult with the board’s attorney on questions and issues pertaining to the board’s powers, duties, privileges, immunities, and liabilities”.

At 11:13 a.m. upon a motion by Ms. Keefe, seconded by Dr. Chock it was voted on and unanimously carried to move out of executive session.

Chapter 91, HRS, The Chair called for a recess from the meeting at 11:13 a.m. to discuss and Adjudicatory Matters: deliberate on the following adjudicatory matter(s) pursuant to Chapter 91, HRS:

In the Matter of the Miscellaneous Permit of California Pharmacy and Compounding Center, Inc.; PHA 2015-99-L, Settlement Agreement Prior to Filing of Petition for Disciplinary Action and Board’s Final Order; Exhibit “1”