New Hampshire Board of Pharmacy Rules Update and

New Hampshire Board of Pharmacy Rules Update and Legislative Review Michael D. Bullek BSP R. Ph. Administrator/Chief of Compliance New Hampshire Board of Pharmacy 1

Nothing to Declare: �Ex-Pharmacy Manager- Rite Aid Plymouth �Advisory Council- Plymouth State University Nursing Program �Adjunct professor of Pharmacology- Plymouth State University �Plymouth School Board – Chairman �Commissioner, New Hampshire Board of Pharmacy 20112017 2

Today’s discussion: �New rules and rules changes �Pharmacy ethics �Legislative issues �Prescription Monitoring Program update 3

The Audit of 2017: �Prescription Drug Monitoring Program �Financial Audit of 2008 �Compliance Audit of 2015 � 216 pages, 26 observations of what we do wrong……. . �Plan and time line presented and approved to Legislature……. will bring a lot of change to how Board office operates. 4

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Rules: �Rules currently in legislative process �Rules in Review �Pending rules issues 6

JLCAR: �Joint Legislative Committee on Administrative Rules 7

Rules in Legislative Process: �Advanced Practice Technicians- Ph 1800 (New) �Quality Assurance Ph (New) �Technician rules (Ph 800) update �Intern rules (Ph 1600) (Issue with vaccinations) �PDMP funding proposal 8

Rules in Review: �Ph 300 �Ph 400 �Ph 700 (audit revisions) �Ph 2100, 2200, (new from audit) 9

Pending Issues: �Inspection rules �Violation notices �CVS rules request �On-line 106 forms �Sterile compounding vs. reconstitution 10

Collaborative Practice: �Approved final review JLCAR 11/16/17 �Final Board approval 12/11/17 �Rules approved 1/17/18 There will be no practice site restrictions with updated rules. 11

Pending Issues: � 318: 16 -a Standards for Collaborative Pharmacy Practice. – I. For a pharmacist to participate in a collaborative pharmacy practice agreement, the pharmacist shall: (a) Hold an unrestricted and current license to practice as a pharmacist in New Hampshire. (b) Have at least $1, 000 of professional liability insurance coverage. (c) Have earned a Pharm. D. degree or completed 3 years of institutional clinical experience as a licensed pharmacist. (d) Complete at least 5 contact hours or 0. 5 continuing education units of board-approved continuing education each year. Such continuing education shall address the area or areas of practice generally related to the collaborative pharmacy practice agreement or agreements. The continuing education hours may be applied to the requirements for licensure as a pharmacist in this state. (e) In order to administer drugs by injection, have completed training that includes programs approved by the Accreditation Council for Pharmacy Education (ACPE) or curriculum-based programs from an ACPE-accredited college of pharmacy or state or local health department programs or programs recognized by the board. The agreement is between the provider and the pharmacist. The provider will set all the requirements of the collaborative practice. 12

Quality Assurance: �HB 469 �Establishing a continuous quality improvement program for pharmacies �Ph 1701. 01 Purpose. The purpose of this chapter is to implement and regulate continuous quality improvement programs. The purpose of these programs shall be to assess errors that occur in the pharmacy in dispensing or furnishing prescription medications so that the pharmacy shall take appropriate action to prevent a recurrence. The purpose of the program is non-punitive and seeks to identify weaknesses in workflow and make appropriate corrections to improve. 13

Quality Assurance: � Ph 1704. 01 Each pharmacy’s continuous quality improvement program shall meet the following minimum requirements: � Meet at least once each quarter each calendar year; � Have the pharmacy’s pharmacist in charge in attendance at each meeting; and � Perform the following during each meeting: � Review all incident reports generated for each reportable event associated with that pharmacy since the last quarterly meeting; � For each incident report reviewed establish the steps taken or to be taken to prevent a recurrence of the incident; and � Create a report of the meeting including at least the following information; � A list of persons in attendance; � A list of the incident reports reviewed; and � A description of the steps taken or to be taken to prevent recurrence of each incident reviewed. �Quarterly reports available on Board inspection 14

Quality Assurance: �Quality Assurance statute approved and is in effect now. �Board will not enforce requirements until rules approved this winter. �Anticipated 6 months before rules in effect. 15

CVS Rules Request: �PART Ph 207 RULEMAKING PETITIONS �Ph 207. 01 Rulemaking Petitions. �(a) A person may request the adoption, amendment, or repeal of a board rule by filing an original and 2 copies of a rulemaking petition with the board. �Ph 207. 03 Action on Rulemaking Petition. �(a) Within 30 days after the submission of a rulemaking petition, the board shall either grant or deny the petition and: 16

CVS Declaratory Ruling: �Request included inclusion of rules for Tele pharmacy and also definition of “presence of a pharmacist in a pharmacy” What is your definition of: �“Presence of a pharmacist” 17

Tele-pharmacy: �Tele pharmacy rules will be developed in near future. Pharmacist presence was denied based on current statutes and rules �Where does tele-pharmacy lead us? 18

Ph 1200 – Central Fill Pharmacy: � Ph 1202. 01 “Central fill pharmacy” means a licensed pharmacy, in this or any other state, district or commonwealth of the United States, engaging in central prescription handling by filling, refilling, or both, prescriptions including the preparation, packaging, and labeling of the medication. � Ph 1202. 02 “Central prescription processing” means “central prescription processing” as defined in RSA 318: 1, XXIII, namely, “the processing by a pharmacy of a request from another pharmacy to fill or refill a prescription drug order or to perform processing functions, such as dispensing, drug utilization review, claims adjudication, refill authorizations, and therapeutic interventions. ” �Chains use the term “workflow balancing” 19

Ph 1202. 03 – Central Processing Pharmacy: Ph 1202. 03 “Central processing pharmacy” means a licensed pharmacy, in this or any other state, district or commonwealth of the United States, that engages in prescription review by performing functions that include but is not limited to: (a) Data entry; (b) Prospective drug review; (c) Refill authorizations; (d) Interventions; (e) Patient counseling; (f) Claims submission; (g) Claims resolution; and (h) Adjudication. 20

Wedding Bells? So……. what do you think a marriage of “central fill processing/workflow balancing” and advanced practice technicians is going to do? We will get to that……. . 21

Ph 300 �CHAPTER Ph 300 LICENSING OF PHARMACISTS AND PHARMACIES �PART Ph 306 PHARMACY PERMITS - CHANGES IN SUPPORTING DATA � Ph 306. 02 Reporting Changes �The chapter will be split, ph 300 will be for pharmacists. �Ph 1900 will be new section of rules dealing with pharmacies. 22

Ph 400 �PART Ph 401 RENEWAL AND REPLACEMENT LICENSES � Now on line registrations � Legislative proposal to biennial licensing September 2018 �PART Ph 402 DISCIPLINARY MATTERS � Updated violation notices etc. � New rules included in ph 2100 inspections and ph 2200 investigations �PART Ph 403 CONTINUING EDUCATION REQUIREMENTS � Will require 2 credits in CQI once rules approved � Addition of 2 credits Law � Annual requirements 23

Proposed Ph 700 Changes �CHAPTER Ph 700 STANDARDS OF PRACTICE Many changes to this chapter. Moving rules specific to “pharmacists” and “pharmacies” to chapters 300 and 1900 �PH 702. 01 Area, Space and Fixtures � Designated area for vaccinations of adequate size and design to ensure patient confidentiality. �Ph 702. 05 Limitations on Access. (d) The pharmacy permit shall be issued to the pharmacy in the name of the pharmacist-in-charge, who along with the permit holder shall have sole control and responsibility for the operation of the pharmacy in accordance with all laws and rules pertaining to the practice of pharmacy in this state and always in the best interest of public health and safety. 24

Proposed Ph 700 Changes �Ph 704. 04 Transfer of Prescriptions. � (1) New or on hold prescription orders for ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCES (EPCS) may transfer an original unfilled prescription from hold. �Ph 704. 08 Prescription Pick-up and Delivery � (1) All schedule medications dropped off shall present picture identification and noted on hard copy of prescription. � (2) All schedule II medications picked shall present picture identification to pharmacy staff. Verification shall be noted in readily retrievable fashion or noted on hard copy prescription. � (3) Mail order pharmacies dispensing new schedule II medications to the patient shall have a “face-to-face” counseling or electronic equivalent and documentation readily retrievable on request by Board. � (a) Patients receiving greater than 100 morphine equivalent dose shall be counseled on availability and use of naloxone. 25

Proposed Ph 700 Changes � Ph 704. 10 Out-of-State Prescriptions. � Prescriptions written by physicians for controlled substances in a state other than New Hampshire may be dispensed to a patient only when the traditional physician-pharmacist-patient relationship exists. � Physicians Prescriptions for controlled substances in Schedule III -IV may be filled for no more than a 34 day supply. � Physicians Prescriptions for controlled substances in Schedule II may be filled if originating from border states, Rhode Island, and Connecticut for no more than a 34 day supply. This will require a statute change (legislation) � Don’t think this one will fly…. snowbirds!!!! � 26

Proposed Ph 700 Changes �Ph 706. 03 Patient Counseling. � Removing mandatory counseling requirement? � Addition of counseling on opioids? � Mail order pharmacy increased requirements? � ? ? ? Lots of discussion, need pharmacist involvement!!!! �g. Proper storage; � (1) Risks of keeping used medications and options for disposing of unused medications. � (i) A pharmacist shall make a reasonable attempt to verify all Control Drug Medication information with the Prescription Drug Monitoring Program. � (1) Pharmacy shall develop and have readily retrievable a policy for verification with Prescription Drug Monitoring Program. 27

703. 04 – Controlled Drug Losses The pharmacist-in-charge or pharmacist on duty shall report to the board in writing, any theft or significant loss of controlled substances within one business day. The pharmacist-in-charge shall complete a New Hampshire Drug Loss Form (revised 5/2015) or DEA 106 Form and mail or fax to the board as soon as the investigation into the loss is complete or within 30 days of the discovery of the loss. b. All instances of diversion shall be reported with one business day. 28

703. 04 – Controlled Drug Losses (c) A pharmacy shall keep a perpetual inventory for all Schedule II drugs and actual counts shall be verified monthly. The inventory reports shall be maintained for a minimum of 2 years. (d) A pharmacy shall consider a controlled drug loss to be significant when: 1. The percentage of dosage units of a specific drug exceeds 2% of monthly dispensing volume; or 2. Fifteen or more dosage units are not accounted for. Attached to PIC and pharmacy permit. Excessive number of losses reported to Board. (Again…. Audit) 29

Break Policy 30

Break Policy �Ph 704. 01 Presence of Pharmacists. �(a) No pharmacist shall work more than 8 hours without a rest break of 30 minutes. Breaks shall be scheduled as close as possible to the same time each day so that patients may become familiar with the approximate break times. �(b) Whenever the prescription department is staffed by a single pharmacist, the pharmacist may take a rest break of a period of 30 minutes without closing the pharmacy an removing support personnel from the pharmacy, provide that the pharmacist reasonably believes that the security o the prescription drugs will be maintained in the pharmacist’s absence. 31

Break Policy �How many of you take a 30 minute uninterrupted break? �What are the barriers? �How to we fix? 32

Rest break survey Compliance visited 128 pharmacies Total % of Total average Total number break number of of RPh Total number of technicians of all interruptions interrupted answering of pharmacies answering personnel reported by breaks in 3 survey RPh tech months 215 62 277 128 15. 34% 35. 48% 5. 24 % of Total % of pharmacies total % of RPh pharmacies with phone overlap that close for messages lunch 24. 20% 55. 40% 11. 70% 33

Ph 800: Pharmacy Technicians �(a) “Registered pharmacy technician” means a person employed by a pharmacy who can assist in performing, under the supervision of a licensed pharmacist, manipulative, nondiscretionary functions associated with the practice of pharmacy and other such duties and subject to such restrictions as the board has specified; and �(b)Certified pharmacy technician” means a registered pharmacy technician who has become and who maintains national certification by taking and passing an exam recognized by the board for the purpose of certifying technicians. 34

Registered Pharmacy Technician �Registered Pharmacy technician: �All personnel working within the pharmacy are to be licensed as “registered pharmacy technicians” � Cashiers � Delivery personnel (NOT Required if specific) � Billing/data entry �Registered Pharmacy technicians with duties that include data entry of prescriptions without direct supervision � Need to take and update annually of board approved competencies in data entry 35

Register Technician Duties �Ph 807. 02 Registered Pharmacy Technician duties. Registered pharmacy technician’s duties shall include: � (a) Non-discretionary functions within the pharmacy concerning cashier, stocking, delivery, and other non-clinical functions necessary for pharmacy operation under the supervision of a licensed pharmacist or certified pharmacy technician; � (b)The counting, weighing, measuring, pouring, and reconstitution of non-parenteral prescription medication or stock legend drugs and controlled substances; � (c) Performing stocking or replenishment of automated dispensing machine, other automated dispensing equipment or other stock locations. Products shall be verified by a pharmacist or certified pharmacy technician. Bar-coding, radio frequency identification, or another form of electronic verification shall be used at the time of stocking or replenishment, or a licensed health professional shall check the medication before administration; and � (d) Registered pharmacy technicians in training to become certified may perform the duties of a certified pharmacy technician under the direct supervision of a pharmacist or certified pharmacy technician. 36

Certified Pharmacy Technicians � Ph 808. 01 Certified Pharmacy Technician Qualifications. � (a) An applicant for a certified pharmacy technician shall: � (1) Be at least 18 years of age; � (2) Have a high school or equivalent diploma; � (3) Obtain and maintain national certification from a nationally recognized certifying organization, such as the Pharmacy Technician Certification Board or the National Healthcare Association; � (4) Not have been convicted of a drug related felony or admitted to sufficient facts to warrant such a finding; and � (5) Seek certification from the board within 15 days of the start date of employment as a Certified Pharmacy technician, and be verified by the pharmacist-in-charge within 30 days. � (b) A registered pharmacy technician seeking certified status shall obtain and maintain certification from a nationally recognized certifying organization, such as the PTCB or the NHA, within one year of entering into a certified pharmacy program. � (c) A New Hampshire certified pharmacy technician with duties involving sterile and nonsterile compounding, shall complete a board approved training program before participating in those duties. 37

�Ph 812. 01 Determination of a Certified Pharmacy Technician’s Duties. � (a) Any certified pharmacy technician who does not maintain national certification shall notify the board and the pharmacist–in-charge immediately of the lapse of certification. Those whose certification has lapsed shall be permitted to perform the duties of a registered pharmacy technician, but shall no longer perform the additional duties of a certified pharmacy technician. � (b) A certified pharmacy technician shall only perform such tasks and duties which are prescribed by the permit holder or pharmacist-in-charge based upon the needs of the pharmacy. �(c) A certified pharmacy technician’s duties may be further limited by the pharmacist on duty or the supervising pharmacist. � (d) Any training given under the direction of a pharmacist shall be documented by the pharmacist-in-charge and be retrievable upon inspection. 38

Certified Technician Duties � (a) A certified pharmacy technician’s duties shall include: � (1) Any duties performed by registered pharmacy technicians under Ph 807. 02; � (2) Accepting a new oral telephone order; � (3) Accepting an oral refill authorization from a provider; � (4) Communicating a prescription transfer for a non-control medication to or from another pharmacy that does not maintain a common database; � (5) Communicating orally or in writing, any medical, therapeutic, clinical, or drug information, or any information recorded on a patient profile that does not require professional judgment; � (6) Performing the data entry of a prescription or medication order into the computer without supervision; � (7) The task of reducing to writing a prescription left on a recording or message line; � (8) Preparing or compounding sterile and non-sterile compounds with additional training; � (9) Verifying stock replenishment medications against the stocking/replenishment system, report or label prior to the stocking/replenishment of the automated dispensing machine, other automated dispensing equipment, or other stock location provided that bar-coding, radio frequency identification or another form of electronic verification is used at the time of stocking/replenishment, or a licensed health professional checks the medication before administration to the patient; � (10) Clarification of an original prescription or drug order with a practitioner or authorized agent of the practitioner; and � (11) Preparation, verification, and sealing of an emergency kit. 39

Continuing Education-Certified �Completed 10 CEU’s if Certified Technician � 2 CEU’s in didactic setting � 2 CEU’s on error prevention or patient safety �Completed compounding requirements � 2 CEU’s in sterile and non sterile compounding �Note non-sterile requirement!! �These are annual requirements! 40

Ph 1800: Advanced Practice Pharmacy Technicians �Rules approved by Board August 2017 �Pulled back for further review after CVS declaratory ruling on tele pharmacy raised concerns…… �Currently under board review and moving through approval process. 41

Ph 1800: Advanced Practice Pharmacy Technicians �(a) “Registered advanced pharmacy practice technician” means a person employed by a pharmacy who can assist in performing, under the supervision of a licensed pharmacist, manipulative, nondiscretionary functions associated with the practice of pharmacy and other such duties including product verification of a prescription refill in which no changes have occurred as well as verification of automation machine refilling or repackaging unit 42 -dose.

Ph 1300: Vaccines � AN ACT relative to vaccines administered by pharmacists. � 1 Vaccines Administered by Pharmacists; Vaccines Added. Amend RSA 318: 16 b to read as follows: � 318: 16 -b Pharmacist Administration of Vaccines. A pharmacist may administer influenza vaccines to the general public and a pharmacist may administer pneumococcal [and], varicella zoster, hepatitis A, hepatitis B, Tdap, MMR, and meningococcal vaccines to individuals 18 years of age or older, provided all of the criteria in this section have been met. The pharmacist shall: � I. Hold a current license to practice as a pharmacist in New Hampshire. � 2 Effective Date. This act shall take effect January 1, 2018. �NOTE: You cannot administer tetanus vaccine just because it is included in Tdap!!! You can administer hepatitis A and B combination products!! 43

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Ph 2100: Inspection Rules �Currently no rules regarding the inspection process �Board current responsibilities to inspect every place there are drugs in state…. . . �Cited in Legislative Audit of 2008 and 2015 as an issue. �Board inspections do not hold permit holders accountable to rules �A need to develop a risk-based inspection process. �Required to include PDMP program in inspection process 45

Ph 2100: DRAFT Inspection Rules �Inspections shall be for the following registrants licensee’s as follows: �Retail pharmacies- annually or based on risk assessment low, medium, high risk �Institution pharmacies (hospitals, stand-alone emergency departments and long term care facilities) –annually �Compounding pharmacies –annually �Public Health and Methadone Clinics- annually �Practitioner/Clinic inspections – every 5 years �Veterinarians/veterinary clinics- every 3 years �Manufacturer/Wholesaler- every 3 years �Limited Retail Drug Distributor- every 3 years 46

Ph 2100: DRAFT Inspection Rules �The following facilities possessing control substances shall be inspected every two years: �Practitioner/Clinics �Veterinarians/veterinary clinics �Inspections with past issues or disciplinary actions will be conducted annually until compliance deems issues resolved or at request of Administrator/Chief of Compliance. �Compliance staff will review pharmacies annually to assess risk and make recommendations to the board. 47

Pharmacist Report Cards �More good news from the audit……. . �Most information will come from licensing… �Precursor to pharmacist credentialing. 48

Violation notices �A violation notice shall be given as a notification of non -compliance with Federal, State, or local laws. � Minor violations will be administrative in nature. � Example: Nametags, paperwork issues etc. � Minor violations shall be issued as a needs improvement, verbal warning, or violation with fine. � Repeat minor violations will result in Board review with consideration for further disciplinary action. 49

Major Violations � Major violations will be administrative in nature. � Example administrative- refrigerator temperature logs � The Pharmacist-in-charge and/or the pharmacist on duty at time of violation is responsible for completing violation notice within 15 days of issue. � Violation notices shall be returned to the Board investigator/inspector in writing with corrected action noted. � Subsequent or multiple violations may result in further action by the board � Investigators/inspectors shall follow up written violation notices no later than 60 days after action noted. � Major violations, after board review, shall be maintained in pharmacist and permit holders permanent file. 50

Major Violations cont… �Violation notices for practitioners shall be forwarded to respective Boards � Violation notices of RSA 318(b) under pharmacy statutes may result in a fine by Board of Pharmacy � Follow up for violation notices shall be responsibility of Board of pharmacy. �Regulatory boards may make a request of pharmacy board investigators/inspectors for follow up on board actions. 51

Ph 2200 Investigations (Draft) �Another audit issue that stated we needed to have the investigation process in rules �QRE report – pharmacists OWN words of issue, NOT corporates!! �Will be in rule and will be enforced �Corporate will have opportunity to file separate QRE report �Investigations involve professional misconduct and standards of practice issues. �Are reviewed by the Board and can result in actions against your license. �Result can be dismissal, letter of concern, disciplinary actions 52

�Actions that result in professional misconduct are reported to national databases and affect your license status. �Regardless of violation or investigation you have the right to a hearing before the Board! 53

Medicaid Dispensing Issue �If a patient has current Medicaid eligibility, there prescriptions must be filled using the proper insurance!!!! �No filling for cash allowed under Medicaid contracts!! �This is a PDMP and diversion issue!! 54

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� ETHICS

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Corresponding responsibility �Time for a discussion……. ………. Where do we draw the line? ? � 58

21 CFR 1306. 04(a) § 1306. 04 Purpose of issue of prescription. (a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U. S. C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. 59

Ethics �Patient with two dislocated shoulders presents with RX from emergency room for Percocet 5/325 mg 1 -2 tabs PO q 4 -6 h prn pain #20 Would you fill this prescription? 60

Ethics �Partial fill of a CII RX 61

Ethics �Board receiving too many inquires and complaints from providers and patients �Legislators threatening action…. . current system not in best interests of patients �Medical Boards stakeholders meeting 62

Ethics �Female patient presents to your pharmacy with the following prescription: Buprenorphine 8 mg s. l. Take 4 tabs PO QD #120 Would you fill this prescription? Concerns? What questions would you ask? 63

Source: Adapted from Vermont Buprenorphine Guidelines. http: //dvha. vermont. gov/for-providers/buprenorphine-practice-guidelines-revisedfinal-10 -15. pdf � 1. These general guidelines should be followed for patients physically dependent on opioids. Patient-specific factors such as: age, comorbidities, other risks, etc. must be considered when dosing buprenorphine. � d. Make sure the patient is not on methadone or other long-acting opioids as buprenorphine may precipitate withdrawal if it too closely follows long-acting opioids. (If patient is on methadone, see Subsection 2 below). � e. Day 1: Give the patient a prescription for 2 doses of 2 mg (or equivalent) of buprenorphine with naloxone. � f. Patient takes the prescription to the pharmacy and returns to the office with the medication. � g. Patient self-administers the medication according to physician’s guidance and product instruction in office. � h. Target buprenorphine dose range should be 6 mg to 12 mg (or equivalent) per day, with a recommended maximum of 16 mg daily. � i. If more than an 8 mg (or equivalent) dose is needed, gradually increase the dose in 2 mg (or equivalent) increments over the next several days. 64

Ethics �Patient also presents a prescription for �Alprazolam 0. 5 mg 1 tab PO BID prn #60 Would you fill this prescription? Concerns? 65

Tennessee Board of Pharmacy Adopted Nonresidential treatment guidelines � Address benzodiazepine co-prescribing � Prescribing of buprenorphine without naloxone 1. Buprenorphine with naloxone product formulations are the treatment of choice for all patients except those who are pregnant, nursing, or have a documented adverse reaction or hypersensitivity to naloxone. a. An adverse reaction or hypersensitivity to a buprenorphine with naloxone product is rare. If a provider is prescribing buprenorphine without naloxone, due to adverse reaction or hypersensitivity, to more than 5% of their patients receiving a buprenorphine-containing product, the provider should reevaluate his/her practice habits and may be subject to review by the Boards of Medical Examiners or Osteopathic Examination. All patients receiving buprenorphine without naloxone shall have proper justification documented in the patient’s medical record. � Counseling requirements � Importance of inter-professional collaboration 66

�Who can prescribe Buprenorphine? � Any physician with a special "X" number issued by the DEA. The way the law is written, any doctor can prescribe Suboxone for treating pain, however the FDA has not granted approval for Suboxone to be used for pain, so it would be an off-label prescription. 67

Ethics �Due Diligence �What is in the best interest of the patient? 68

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RSA 318 – B: 15 318 -B: 15 Persons and Corporations Exempted. – The provisions of this chapter restricting the possession and having control of controlled drugs shall not apply to: IV. (a) A health care professional authorized to prescribe an opioid antagonist may prescribe, dispense, or distribute, directly or by standing order, an opioid antagonist to a person at risk of experiencing an opioid-related overdose or a family member, friend, or other person in a position to assist a person at risk of experiencing an opioid-related overdose. Any such prescription shall be regarded as being issued for a legitimate medical purpose in the usual course of professional practice. 70

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Naloxone �Naloxone survey results for DHHS �Access better than anticipated �Usage numbers poor � 215 pharmacies responded to survey. Excellent response!!!!!! 72

21 CFR 1306. 04(c) § 1306. 04 Purpose of issue of prescription. (c) A prescription may not be issued for "detoxification treatment" or "maintenance treatment, " unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements in § 1301. 28 of this chapter. Lets talk about methadone………

Legislative Issues Affecting Pharmacy �There were 24 bills affecting pharmacy and Board operations in last legislative session �The Board had opinion and testified on the majority of the legislation. �Vaccinations were a hot topic, as 4 bills were presented, most removing vaccines from current list of pharmacist administered, all inexpedient to legislate. �There were 7 bills presented concerning pharmacy benefit managers with some being merged and with two passed. �The Board opposed one bill and changed one to pharmacy rules.

Legislation �SB 333 relative to pharmacy interns and vaccinations (RSA 318: 16 ) �Increased vaccinations under direct pharmacist supervision. �Hepatitis A and B, Tdap, MMR and meningococcal. �SB 486 establishing a commission to study enhancing the prescription drug return program. �Many issues with this, current law will limit

Original version 318. 1(III)(a) �III-a. "Compounding'' means the preparation, mixing, assembling, packaging or labeling of a drug or device as a result of a practitioner's prescription drug order or initiative based on the pharmacist-patientprescriber relationship in the course of professional practice or, for the purpose of, or as an incident, to research, teaching, or chemical analysis, but not selling or dispensing. "Compounding'' also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regular observed prescribing patterns. "Compounding'' shall not include the reconstitution of powder formulation before dispensing or the addition of flavoring.

Amendment added �“Compounding” shall not include the simple addition of flavoring, nor shall it include the preparation of a single doe of a non-hazardous commercially available drug or licensed biologic for administration within 2 hours of preparation to an individual patient when done in accordance with the manufacturer’s approved labeling or instructions consistent with that labeling

Legislation �SB 573 -FN-A Relative to the controlled drug prescription health and safety program and making an appropriation therefor. �Bill allows for chief medical examiner and delegates to register and access PDMP program �Also makes appropriation to PDMP (2 nd part of funding proposal). �SB 332 Relative to medication synchronization �Requires insurers offering health insurance policies with prescription drug coverage to allow covered persons to synchronize the dispensing dates of their prescription drugs. �Does not include controlled substances!

Legislation �HB 1606 Relative to naturopathic health care practices �Are medical providers by statute �Pharmacy Board shall provide inspectional services �Add a member to PDMP advisory council. �Formulary available on line �SB 376 -FN Relative to the sale of certain cold medications �Regulates the sale and possession of products containing ephedrine and pseudoephedrine �Allows for sale, providing follows federal reporting guidelines in any retail establishment. �Located in RSA 318, under Board control? Inspections?

Legislation �SB 483 relative to procedures for dispensing controlled drugs � Interim study by House HHS committee � To be placed in pharmacy rules. � Requires picture ID at drop-off and pickup of RX. � If RX picked up by someone else will require authorization by patient. �HB 1791 -FN Allowing pharmacists to disclose information relative to lower cost drugs under the managed care law and relative to biological products dispensed by pharmacists � Removes “Gag rule” on informing patient of lower cost availability. � Requirements for substituting biological products

Legislation �HB 1822 -FN making hormonal contraceptives available directly from pharmacists by means of a standing order. �Result of study commission established in 2017. �Was our best chance for provider status. �Allows pharmacist to charge for an initial screening and payment by insurance carrier. �Standing order an issue, HHS medical director to sign blanket order? ? ? �Specific education requirements. �Don’t expect rules until winter.

Legislation �SB 421 Relative to insurance coverage for prescription contraceptives �Allows for dispensing of a 12 month supply on maintenance therapy. �Initial RX for 3 month supply. �HB 1746 -FN Relative to the practices of pharmacy benefit managers �Credentialing bill �States Board of Pharmacy only entity that can credential pharmacist’s �Will sunset June 20 th, 2020

Legislation �SB 481 Establishing a committee to study the impact of pharmacy benefit manager operations on cost, administration and distribution of prescription drugs. �Major bill on regulation of PBM’s �Combination of 7 bills for discussion

Some Legislative Initiatives… �Biennial licensing – ready for 2018 -2019 �PDMP updates from audit �Control drug prescribing �Return to 100 dosage units or 34 day supply? ? ? �Buprenorphine prescribing statute�Staffing ratios�? ? ? ?

PDMP Data Audit & Compliance Project �To assist with improving data and making better linkages – the PDMP will receive CDC funds to hire temporary staff (PT Asst. Pharmacy Inspector and a PT Pharmacist) to implement a PDMP Audit: �Determine New Hampshire’s PMP data accuracy by: �Implementing a standardized process for evaluating its accuracy �Taking the necessary steps to correct the data if errors are identified �Prevent incidences of errors

PDMP Funding � 2014 to Current – Received three grants from the Bureau of Justice Administration (BJA-Harold Rogers Grant). SUSTAINABLE FUNDING PLAN: � SB 573 - Appropriation. There is hereby appropriated an amount equal to 5 percent of the revenue collected on behalf of the following boards for the biennium ending June 30, 2019 to the controlled drug prescription health and safety program established under RSA 318 B: 32: pharmacy board, board of medicine, board of nursing, board of dental examiners, board of veterinary medicine, naturopathic board of examiners, board of podiatry, and the board of registration in optometry. � Increasing fees for out of state pharmacies and apply these fees to support the ongoing program costs for the NH PDMP.

Questions or Comments