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HB 2879 Advisory Group Brainstorming Session Meeting Notes ... · infrastructure (IT, equipment,...
Transcript of HB 2879 Advisory Group Brainstorming Session Meeting Notes ... · infrastructure (IT, equipment,...
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Oregon Board of Pharmacy – 2015
Meeting Notes
HB 2879 Advisory Group Brainstorming Session
July 30, 2015, 9-11am
Board of Pharmacy; 800 NE Oregon Street Portland 97232
ATTENDEES Marc Watt, BOP Nicole Krishnaswami, OMB Fiona Karbowicz, BOP Sarah Wickenhagen, OSBN Gary Miner, BOP Kevin Smith, BOP Intern
Christy Cowgill, OSBN Crystal Bryan, Fred Meyer
Emily Elman, OHA Lorinda Anderson, OSU Connie Clark, OHA
Unable to Attend: Helene Rimberg, OHA; Dr. Carrie Miles, Dr. Peter Palacio
Agenda Item Desired Outcome
Welcome Introductions. Marc Watt provided an overview of the process to the committee. An early focus of the group is to decide upon the essential elements of the mandated training/education program, as the other components will intuitively follow from there. We have reached out to the only ACPE CE provider in the state, who has the existing infrastructure (IT, equipment, etc.) to develop the program. Additionally, we envision the development of a protocol with algorithms based on the USMEC and ACOG guidelines for pharmacists to utilize in prescriptive decision-making (product selection and the handling of side effects). This will provide a level of comfort with the process as well as promote consistency among those participating throughout the state. The details for rules will follow directly from these efforts, and, finally, will allow for participating pharmacists to complete the training and pharmacies to develop policies & procedures for implementation at their locations.
Components of HB 2879
The group discussed the bill, as enrolled – HB 2879 – key components include:
Pharmacist prescriptive authority
Self-administered oral hormonal contraceptives and patch
BOP to establish rules and standard procedures in consultation with OMB, OSBN, OHA and in consideration of ACOG guidelines. Must include:
Training/education program
Based on self-screening risk assessment tool used by patient
Notification/referral to practitioner
RPH shall not require the patient to schedule an appointment and cannot continue to prescribe and dispense without evidence of a clinical visit within 3 years
HB 2879 Committee- Work Planning
Timeline overview
Goal: ‘up and running’ by January 1, 2016 -Training/education components known asap in order to facilitate program’s development.
Currently drafted as 5 modules:
Family Planning and Birth Control Options
MOA of Hormonal BC
Foundation of Hormonal Contraception
Risks, Counseling Points and the Self-Screening Risk Assessment Tool
Creating a protocol or work-flow when seeing patients -Training/education program completed in time to allow RPH to start training prior to Jan 2016 -Rules drafted by mid Q4 in order to allow pharmacies to develop P&P -Communications and outreach will be ongoing
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Oregon Board of Pharmacy – 2015
Discussions Discussions among the group included the following topics:
Comprehensive review of the Self-Screening Risk Assessment Tool
Components of the Protocol and decision-making algorithms
Components of the “toolkit” that will be created for participating pharmacists
Components of the rules/protocol to include:
Accommodations to ensure confidentiality
When to refer to clinician
Continuing education requirements
Record-keeping and charting
Reimbursement considerations
Partnerships with local county health, family planning and clinics
Good of the Order Next steps – Review of materials by participants Deliverables and due-dates Preferred method of communication Meetings schedule – A ‘Doodle Poll’ will be sent out. Plan to meet bi-monthly initially.
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Agenda HB 2879 Advisory Committee Meeting
August 26, 2015, 1:30-3:30pm Board of Pharmacy; 800 NE Oregon Street Portland 97232
ATTENDEES
Unable to Attend:
Agenda Item Desired Outcome
Welcome
Introductions
Review of Brainstorming Session 7.30.2015
Discussion items:
Components of HB2879
Committee’s Timeline Overview
Brainstorming and Conversations
Review and approve draft minutes HB 2879 Protocol and Decision-Making Algorithms
Homework: Review draft protocol and algorithm templates
Discuss and decide “Referral” Points
Discuss and decide Pregnancy assessment
Discuss and decide BP
Discuss and decide Initiation Strategies (initial/change in treatment) counseling points
Discuss “Quick Start”
Other?
(if time allows) Preview Follow-Up Questionnaire (changes in treatment) Good of the Order Next steps
Begin conceptualizing Rules
Begin developing Appendices for participating pharmacists and pharmacies
Other?
Oregon Board of Pharmacy – 2015
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Meeting Notes
Oregon Board of Pharmacy – 2015
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Oregon Board of Pharmacy – 2015
Minutes
HB 2879 Advisory Committee Meeting
August 26, 2015, 1:30-3:30pm
Board of Pharmacy; 800 NE Oregon Street Portland 97232
ATTENDEES
Lorinda Anderson Pete Palacio (phone) Roberto Linares Helene Rimberg
Marc Watt Connie Clark Fiona Karbowicz Sarah Wickenhagen Gary Miner Nicole Krishnaswami
Christy Cowgill Crystal Bryan
Unable to Attend: Emily Elman
Agenda Item Desired Outcome
Welcome Introductions
Review of Brainstorming Session 7.30.2015
We had a brief review of the following discussion items:
Components of HB2879
Committee’s Timeline Overview
Brainstorming and Conversations
Reviewed and approved draft meeting notes from 7.30.15 meeting
HB 2879 Protocol and Decision-Making Algorithms
Homework: Review draft protocol and algorithm template
Background: The US Selected Practice Recommendations for Contraceptive Use, 2013 (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6205a1.htm?s_cid=rr6205a1_w ) outline “the recommendations intended to help health-care providers address issues related to use of contraceptives, such as how to help a woman initiate use of a contraceptive method, which examinations and tests are needed before initiating use of a contraceptive method, what regular follow-up is needed, and how to address problems that often arise during use, including missed pills and side effects such as unscheduled bleeding.” It is intended to be used in conjunction with the US MEC. Together they provide the guidance for the Advisory Committee’s establishment of the standard procedures for HB 2879 (protocol with algorithms for decision-making).
The committee reviewed the draft protocol and algorithm, step by step, to address the following details:
“Referral” Points – Pregnancy, contraindicating health conditions,contraindicating medications, BP > 140/90
Pregnancy assessment – US SPR “Excluding Pregnancy Checklist Tool” to beused for possibility of pregnancy.
Blood Pressure – Important component to all clinicians polled.
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Oregon Board of Pharmacy – 2015
Initiation Strategies (initial/change in treatment) & required counseling points, including “Quick Start”
Dispensing quantities. The group discussed the rationale for various quantities for initial and refill dispensing and determined that there are a variety of scenarios (cost, pharmacy inventory, concern regarding side effects, etc) for consideration. The group also discussed the “mobility” of the prescription and will continue to discuss “transfers” of prescriptions initiated by pharmacists.
The updated draft is attached:
2879 Basic Algorithm - Updated 9.3.15.xlsx
The Advisory Committee discussed the Follow-Up Questionnaire. The updated draft is attached:
Good of the Order
Next steps
Begin conceptualizing Rules – to be discussed at 9.8.15 meeting
Begin developing Appendices for participating pharmacists and pharmacies – ongoing discussions will address specific appendices for the Pharmacist’s “Tool Kit”. To include a “referral form”.
Discuss statute intent regarding “prescribe and dispense”
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Agenda HB 2879 Advisory Committee Meeting
September 8, 2015 9-11:30am Board of Pharmacy; 800 NE Oregon Street Portland 97232
ATTENDEES
Unable to Attend:
Agenda Item Desired Outcome
Welcome
Introductions
Review of 8.26.15 Meeting
Review and approve draft minutes
HB 2879 Protocol and Decision-Making Algorithms
Review draft protocol and algorithm template updates
“Referral” Points
Pregnancy assessment
Blood Pressure
Initiation Strategies (initial/change in treatment) counseling points
Counseling “Quick Start”
Other?
Review Follow-Up Questionnaire (changes in treatment)
Discuss mandatory requirements vs. items in “toolkit” (aka Appendices)
Clinical Q&A for training program
Discuss statute intent regarding “prescribe and dispense”
Conceptualize Rules Good of the Order Next steps
Rules to be drafted
Communication/Outreach
Other?
Oregon Board of Pharmacy – 2015
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Meeting Notes
Oregon Board of Pharmacy – 2015
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Minutes HB 2879 Advisory Committee Meeting
September 8, 2015 9-11:30am Board of Pharmacy; 800 NE Oregon Street Portland 97232
ATTENDEES
Emily Elman Dr. Pete Palacio (phone) Lorinda Anderson Dr. Maria Rodriguez (phone) Sarah Wickenhagen Roberto Linares (phone) Fiona Karbowicz Crystal Bryan (phone) Marc Watt Julie Miller, BOP Intern
Unable to Attend: Gary Miner, Connie Clark, Helene Rimburg, Nicole Krishnaswami, Christy Cowgill
Agenda Item Desired Outcome
Welcome Introductions
Review of 8.26.15 Meeting
The Committee reviewed and approved draft minutes from the 8.26.2015 meeting.
HB 2879 Protocol and Decision-Making Algorithms
The Committee reviewed draft protocol/algorithm template updates.
Definitive referral points have been incorporated into the mandated Standard Procedures Algorithm
Pregnancy assessment. The Committee approved adding the six follow-up questions for pregnancy rule-out onto Step 2 of the Standard Procedures Algorithm, for the pharmacist to ask, if a woman answers “Yes” to question #1.
The Committee approved the requirement to take blood pressure.
Initiation Strategies (initial/change in treatment) counseling points were discussed and decided to re-organize Step 5 (as seen on current draft).
The Committee approved the requirements for Counseling points to be:
∗ “Quick Start” – Begin today and use backup method for 7 days.
∗ Management and expectations of side effects
∗ Adherence and follow-up visit expectations
Other? Encouragement of routine health screenings, STD prevention and notification to current healthcare provider
The Committee reviewed the Follow-Up Questionnaire (changes in treatment).
The Committee discussed mandatory requirements vs. items in “toolkit”. It has been determined that the Self-Assessment Risk Questionnaire, Standard Procedures Algorithm and Visit Summary are required. The rest of the products will be made available as appendices for reference by participating pharmacists and pharmacies.
Oregon Board of Pharmacy – 2015
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Lorinda Anderson lead a conversation regarding clinical Q&A for the continued development of the training program. Items addresses included handling details of the USMEC and risk factors, actual clinical use of progesterone-only pills and 50mcg doses, routine starter doses, driperinone and PMS/PMDD, antibiotics counseling and cyclical vs. continuous dosing
Marc Watt shared DOJ Counsel’s opinion regarding statute intent for “prescribe and dispense”. The use of the conjunctive word “and” is consistent with prescribing and dispensing being separate actions, as it is also used with “hormonal contraceptive patches and self-administered oral hormonal contraceptives” though there is no rational expectation that both a patch and an oral product be dispensed to a patient at the same time.
The Committee briefly began to conceptualize the rules. Using our typical rule structure, the “skeleton” will look something like the following:
Preamble
Definitions
Advisory Committee Makeup
Training Program
Delivery of Care
Pharmacy Policies and Procedures
Records Good of the Order Next steps
Rules to be drafted
Communication/Outreach
Other?
Oregon Board of Pharmacy – 2015
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Agenda HB 2879 Advisory Committee Meeting
September 22, 2015 1:30-3:30pm Board of Pharmacy; 800 NE Oregon Street Portland 97232
ATTENDEES
Unable to Attend:
Agenda Item Desired Outcome
Welcome Introductions Review of 9.8.15 Meeting
Review and approve draft minutes from previous meeting
Committee Discussions Review final drafts of the Self-Screening Risk Assessment Questionnaire and Standard Procedures Algorithm
Review Follow-Up Questionnaire – Discuss progesterone activities and references utilized for this appendix item
Discuss Appendices
Visit Summary
Health Department locations by area
Available contraceptives (COC and POP list)
Family Planning methods
Patch and pill summary guides
Other??
Detailed review of the draft rules – OAR 855-019-0264 Good of the Order Next steps
Communication/Outreach
Other?
Oregon Board of Pharmacy – 2015
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Meeting Notes
Oregon Board of Pharmacy – 2015
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Minutes HB 2879 Advisory Committee Meeting
September 22, 2015 1:30-3:30pm Board of Pharmacy; 800 NE Oregon Street Portland 97232
ATTENDEES
Helene Rimberg Roberto Linares Emily Elman Marc Watt Nicole Krishnaswami Gary Miner Christy Cowgill Fiona Karbowicz Sarah Wickenhagen Lorinda Anderson
Doan Pham, BOP Intern
Unable to Attend: Pete Palacio, Maria Rodriguez, Crystal Bryan
Agenda Item Desired Outcome
Welcome Introductions Review of 9.8.15 Meeting
The Committee reviewed and approved draft minutes from 9.8.2015 meeting.
Committee Discussions The Committee reviewed drafts of the Oregon Self-Screening Risk Assessment Questionnaire and Oregon Standard Procedures Algorithm. Minor edits to be added and reviewed at upcoming meetings by Pharmacy Board (10.8.2015) and Advisory Committee (10.13.2015). These two documents are specifically named in the draft rules and are therefore essential, required forms to be used by participating pharmacists (and pharmacies).
The Committee reviewed the “Follow-Up Questionnaire”
The title may be misleading and will be renamed to something along the lines of “Re-Evaluation or Alternative Therapy Assessment”
The Committee discussed the appendices, aka “Toolkit”
Visit Summary. Minor edits were made to the language. Additional information lines to be added to the Visit Summary for specific instructions/recommendations for the pharmacist to provide to patient, including notes. The Committee sees the Visit Summary as an important element to these procedures, as it will provide for clear communication to patients and other care providers about the contraceptive prescribed or clear communication why contraception was NOT prescribed. It is also a form mentioned in the draft rules, but the Committee understands that each pharmacy may want to tailor it to their own company. That is authorized as long as they retain all elements set forth by this template.
Health Department locations by area. A list of clinics will be a very useful appendix for pharmacists who must refer patients to a clinician. The Oregon Health Authority (OHA) has this information and shared it with the Committee. It will be included in the appendices.
Available contraceptives (COC and POP list). The Committee has not Oregon Board of Pharmacy – 2015
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definitively made a determination about the necessity of this component.
Family Planning methods
Patch and pill summary guides. The OHA is working on edits to the current forms.
Others? Committee members may continue to suggest additional resources for the group to consider adding to the published appendices.
The Committee began their review of the draft rules. Suggestions included:
Define “Clinical Visit”. OHA and Gary will work on a definition.
Making some of the language more specific and restructuring some sentences in the Training Program section.
Will there be a CE requirement? Group members discussed this and tentatively stated that there is an inherent professional requirement to maintain competency in all areas of practice, however it is to be discussed at the Pharmacy Board meeting on 10.8.2015
Records retention. As this now involves records beyond a traditional pharmacy’s drug dispensing record, the Committee discussed the concept of medical records, “charting”, etc. We will have Board counsel look into statutory mandates.
Good of the Order Next steps
Communication/Outreach
Other?
Oregon Board of Pharmacy – 2015
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Agenda HB 2879 Advisory Committee Meeting
October 13, 2015 1:30-3:30pm Board of Pharmacy; 800 NE Oregon Street Portland 97232
ATTENDEES
Unable to Attend:
Agenda Item Desired Outcome
Welcome Introductions
Review of Previous Meeting
Review and approve draft minutes from 9.22.2015 meeting
Committee Discussions Review final drafts of the Oregon Self-Screening Risk Assessment
Questionnaire and Oregon Standard Procedures Algorithm
Review Re-Evaluation Questionnaire – Discuss progesterone activities and references utilized for this appendix item
Detailed review of the draft rules – OAR 855-019-0400 through 0435
Visit Summary required?
Additional discussion re: Appendices?
Good of the Order Next steps
Board’s Plan and Timeline to “Roll-Out”
Communication/Outreach
Other?
Oregon Board of Pharmacy – 2015
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Meeting Notes
Oregon Board of Pharmacy – 2015
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Oregon Board of Pharmacy – 2015
Minutes
HB 2879 Advisory Committee Meeting
October 13, 2015 1:30-3:30pm
Board of Pharmacy; 800 NE Oregon Street Portland 97232
ATTENDEES
Emily Elman Fiona Karbowicz Helene Rimberg Gary Miner
Lorinda Anderson Nicole Krishnaswami (phone) Christy Cowgill Crystal Bryan (phone) Doan Pham, BOP Intern
Unable to Attend: Dr. Pete Palacio, Dr. Maria Rodriguez, Sarah Wickenhagen, Dr. Carrie Miles, Marc Watt
Agenda Item Desired Outcome
Welcome Introductions
Review of 10.13.2015 Meeting
The Committee reviewed and approved draft minutes from 10.13.2015 meeting
Committee Discussions The Committee reviewed final drafts of the Oregon Self-Screening Risk
Assessment Questionnaire and Oregon Standard Procedures Algorithm to address changes suggested by the Board at the 10.8.2015 meeting.
An asterisk was added to the ‘Age’ line at the top of the Questionnaire as a reminder to confirm DOB with valid photo ID and as a reminder for the bill mandates for prescribing to patients under the age of 18.
For record-keeping purposes, the Questionnaire now contains all the elements to be the valid prescription, with the addition of the sig, pharmacy phone and address lines. A prescription is considered valid pursuant to regulations set forth by OAR 855-041-1105, to include info on the ‘front’ AND ‘back’ of a prescription.
The Committee discussed the US MEC related to Questionnaire #s 6 and 7 to address the nuances between post-partum and breastfeeding. The Committee determined that keeping both questions and making the questions as general as possible will provide the pharmacist with the most information for patient evaluation.
The Committee discussed the Algorithm and no changes were made.
The Committee reviewed the Alternate Therapy/Re-Evaluation Questionnaire that may be used by a pharmacist in Algorithm Step 5b for an alteration of therapy. Lorinda explained the differences in pharmacotherapy textbooks to current practice realities related to progesterone activities.
Pharmacy textbooks tend to categorize “strong” vs. “weak” progesterone activity but the clinical data do not provide evidence to support this, especially when addressing Breakthrough Bleeding (BTB).
When addressing BTB in clinical practice, it is best to discuss adherence and
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Oregon Board of Pharmacy – 2015
smoking, as these are the two primary causes for BTB.
Fiona and Doan will make edits to the Alternate Therapy Questionnaire to incorporate these clinical components and bring the edits to the Committee for future review. (Recall that this document is not required by rule or Algorithm and will simply be put into the “Toolkit” provided by the Board as a reference document.)
The Committee performed a detailed review of the draft rules, now codified as OAR 855-019-0400 through 0435.
The Committee confirmed the Board’s edits made at their 10.8.2015 meeting, with a few exceptions:
o “Clinical Visit” was re-defined, as related to these rules.
o The Committee made slight re-structuring to the Procedural Mandates rule (19-0425) for clarification.
The Committee discussed the Visit Summary rule requirements and determined that while this is a critical document to be provided to each patient, it is not necessary to require the pharmacy to retain it in records. A pharmacy may choose to keep a copy of what the pharmacist gave to the patient, but the Committee stated that all reasons to refer are recorded on the Questionnaire/prescription.
The Committee did not have time to discuss additional Appendices.
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Agenda HB 2879 Advisory Committee Meeting
October 20, 2015 1:30-3:30pm Board of Pharmacy; 800 NE Oregon Street Portland 97232
ATTENDEES
Unable to Attend:
Agenda Item Desired Outcome
Welcome Introductions
Review of Previous Meeting
Review and approve draft minutes from 10.13.2015 meeting
Committee Discussions Review Rules
Review Re-Evaluation Questionnaire – Discuss progesterone activities and recommendations
Overview of Board’s Plan and Timeline
November 4 & 5 Strategic Planning meeting
Temporary and Final Rule schedule
Communications and Outreach Plan
Advisory Committee survey
Toolkit components
Outreach to patients and all licensees
Good of the Order Next steps
Future Advisory Committee meeting schedule
Other?
Oregon Board of Pharmacy – 2015
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Meeting Notes
Oregon Board of Pharmacy – 2015
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Oregon Board of Pharmacy – 2015
Minutes
HB 2879 Advisory Committee Meeting
October 20, 2015 1:30-3:30pm
Board of Pharmacy; 800 NE Oregon Street Portland 97232
ATTENDEES
Emily Elman Crystal Bryan (phone) Helene Rimberg Nicole Krishnaswami (phone)
Fiona Karbowicz Gary Miner Doan Pham (BOP Intern)
Unable to Attend: Marc Watt, Christy Cowgill
Agenda Item Desired Outcome
Welcome Introductions
Review of Previous Meeting
Review and approve draft minutes from 10.13.2015 meeting
Committee Discussions Review Rules
The Committee discussed the merits of having the required educational training be ACPE (Accreditation Council for Pharmacy Education) approved.
It allows for credibility and sets standards for consistency in CE criteria.
Review Re-Evaluation Questionnaire
Regarding progesterone, there is a difference between the pharmacologic activity (or drug potency) and actual clinical prescribing determination.
The training will be addressing the distinctions and this appendix item must be consistent with and reflective of information taught in the training.
Overview of Board’s Plan and Timeline
The Board will be reviewing and potentially adopting Temporary Rules on November 4, 2015. This will include a review and approval of the “Tool-Kit” resources, to allow interested pharmacists and pharmacies to prepare for the January 1, 2016 operative date.
The Board also plans to review and approve the training program that OSU College of Pharmacy has been developing. The committee requests the opportunity to view the training program at a future time.
Communications and Outreach Plan
Dr. Maria Rodriguez has worked with the OHSU IRB to develop a survey. The Committee believes this will be a valuable way to gather data about pharmacist’s awareness and confidence related to this new law.
Tool-kit components are being finished up. The OHA will provide a list of
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Oregon Board of Pharmacy – 2015
family planning and county health clinics, categorized by area of the state. Additionally the OHA may provide a resource “one-pager” about the Affordable Care Act/TitleX directives related to contraceptive care. Links to relevant sources given to our public will also reside in the ToolKit.
The group discussed outreach to patients and all licensees. The OMB and BOP will utilize their newsletters and websites to provide info to licensees. The OHA can discuss this program with their partnerships to spread the word. The more outreach and specific info that we can provide, the better the understanding and support for pharmacist prescribing of hormonal contraceptives.
The group discussed the importance of “cash” pay versus the billing of insurers and understands this is not the work of the BOP, but is a critical element to actual participation and implementation by pharmacists and pharmacies. If and when the Oregon Pharmacy Association can develop a reference for billing and reimbursement, it can be added to the “ToolKit”.
Good of the Order Next steps
Appointment calendar invitations will be sent regarding future Committee meetings, once best availability is determined via “Doodle Poll”.
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Oregon Board of Pharmacy – 2017
Minutes HB 2879/2527 Committee Meeting
July 28, 2017 9:30-11:30am Board of Pharmacy; 800 NE Oregon Street Portland 97232
ATTENDEES
Ruby Jason, Board of Nursing Lorinda Anderson, OSU Maria Rodriguez, OHSU Lincoln Alexander, Albertsons/Safeway Emily Elman, OHA Jenny Kim, Fred Meyer Linda McCauley, OHA Hong Nguyen, Fred Meyer Marc Watt, Board of Pharmacy (OBOP) Tim Frost, Board of Pharmacy
On Phone: Nicole Krishnaswami, Medical Board Facilitator: Fiona Karbowicz, Board of Pharmacy
Agenda Item Desired Outcome
Welcome Introductions
Review of 2017 HB 2527
The committee reviewed 2017 HB 2527. This new law adds the vaginal ring and depo-progesterone to the list of contraceptives that can be prescribed, dispensed and administered by a trained Oregon pharmacist. Some highlights of the law’s language are listed:
In accordance with rules adopted by the State Board of Pharmacy under ORS 689.205, a pharmacist may prescribe and administer injectable hormonal contraceptives and prescribe and dispense self-administered hormonal contraceptives.
“Injectable hormonal contraceptive” means a drug composed of a hormone or a combination of hormones that is approved by the United States Food and Drug Administration to prevent pregnancy and that a health care practitioner administers to the patient by injection
“Self-administered hormonal contraceptive” means a drug composed of a hormone or a combination of hormones that is approved by the United States Food and Drug Administration to prevent pregnancy and that the patient to whom the drug is prescribed may administer to oneself. “Self-administered hormonal contraceptive” includes, but is not limited to, hormonal contraceptive patches and hormonal contraceptive pills.
The amendments to ORS 689.005, 689.683 and 743A.066 by sections 1 to 4 of this 2017 Act become operative on January 1, 2018.
The group had a short discussion on the legislative intent of a pharmacist administering depo (versus dispensing it and having patient self-inject, either IM or Sub-Q). The intent of the law is for administration by a pharmacist. Oregon pharmacists already have the statutory authority to administer a drug (ORS 689.655 and OAR 855-019-0265). A pharmacist should administer when prescribing depo, but for extenuating circumstances, in their professional judgment, might have a reason to dispense. In these rare events, RPH shall document decision and rationale.
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Oregon Board of Pharmacy – 2017
Discussion The committee discussed updates to the ACPE educational training program.
New content related to vaginal ring and depo is endorsed – Lorinda walked through the DMPA training on overhead, including patient care video which incorporated learning objectives and teaching points related to ongoing depo injection therapy.
The committee suggested that the training module be made available to pharmacists prior to January 1, in order to prepare. This will be discussed at upcoming OBOP meeting (August 10, 2017). The program can send messages to all who have enrolled.
Additional training programs to evaluate? None at this time. It is possible that some programs may be in development – Stay tuned.
The committee addressed edits to forms.
Questionnaire
• The addition of DMPA to the contraceptive list prompted the following components to be discussed:
1. Unexplained vaginal bleeding.
a. Proposed to add a new question: Have you had a recent change in vaginal bleeding that worries you? This allows the pharmacist to have a dialogue with patient about recent pap smears, related to intercourse, etc.
b. A YES answer is addressed on the new DMPA Algorithm (Step 5) “Address any unexplained vaginal bleeding that worries patient (Questionnaire #23) - Refer when necessary*
2. Long term corticosteroid (LTC) use. Lorinda and clinicians described the impact on of LTC on certain disease conditions, primarily concerning bone mineral density loss. Group discussed the way to incorporate this topic into the forms.
a. Decision to state “Caution with use of DMPA > 2 years (due to loss of bone mineral density). For therapy > 2 years, consultation with healthcare provider is indicated.” on the DMPA Algorithm.
• Other Questionnaire content discussed:
1. Solid organ transplant.
a. Decision to add liver transplant to Question #18. This is still being discussed.
2. Inflammatory Bowel Disease (IBD).
a. Decision to add a new question (now Question #10) and add to Oregon MEC. Color “code” is dark green.
• Other Questionnaire edits proposed:
1. Move the patient preference question to the top of the form. Includes the addition of vaginal ring and injectable.
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Oregon Board of Pharmacy – 2017
2. Create a new “back” of the form. This is optional and is customizable by the pharmacy.
a. States “Optional – May be used by pharmacy.
This side of form may be customized by pharmacy –Do not make edits to the Questionnaire (front side)”.
b. Includes the “Rx” grey box that used to be on the front.
c. Adds the Pregnancy Screen questions (Algorithm, Step 2).
d. Adds a signature/date line.
MEC
• Added new DMPA category. Includes initiating/continuing columns
• Added IBD; added vaginal bleeding
• Still fitting on two pages!
Algorithms
• Standard
Added corticosteroid prompt to see DMPA Algorithm (Step 3)
Added greater than or equal to BP referral point for clarity
For BP>/= 140/90 referral box, added “or consider POP”
Added “(excluding DMPA)” to title
• New Algorithm for DMPA
Steps 1 and 2 are same
Step 3: Caution long-term corticosteroid therapy and Questions #10, 20 and 21)
Step 4: BP criteria is >/= 160/100 for referral
Step 5: Discussion of DMPA therapy with patient, to include:
a. Address unexplained worrisome vaginal bleeding
b. Expectations and management of side effects
c. Plans for follow-up visits for every 3-month administration of DMPA – Patient shall return within 11-15 weeks of previous injection. Pharmacist shall provide patient with specific calendar date range for next injection
d. Counseling point – Caution with use of DMPA therapy greater than 2 years, due to loss of bone mineral density; Consultation with a healthcare provider is indicated
Step 6 is to prescribe and administer. The algorithm splits at this step into First Dose and Ongoing Administration of DMPA
a. First dose: Pharmacist shall monitor patient for 20 minutes after administration
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Oregon Board of Pharmacy – 2017
b. Ongoing: Pharmacist shall confirm that date of last injection was within 11-15 weeks.
o If > 15 weeks, pharmacist must rule out pregnancy. Repeat Step 2 and document. Instruct patient to abstain or use backup method for 7 days
o If between 11-15 weeks ago, administer DMPA
o Do not administer if < 11 weeks ago
The committee discussed requests from various chains to utilize own questionnaire. It was recommended that at this time, pharmacies must continue to use the Oregon Questionnaire. However, it is also recommended that pharmacies may use the backside of the form for customization.
The committee discussed the proposed edits to the rules in Division 019 and 041. No changes were suggested at this time. Will be reviewed by OBOP at August 10th meeting.
Next Steps?
Fiona to make all suggested edits to forms and will email the committee for review. Committee members will “reply all” with comments to continue this conversation to get all the forms ready for publication prior to January 1, 2018 effective date of the changes.