Michael D. Bullek BSP R.Ph. Administrator/Chief of Compliance New Hampshire Board of Pharmacy

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Michael D. Bullek BSP R.Ph. Administrator/Chief of Compliance New Hampshire Board of Pharmacy 1

Nothing to declare Pharmacy Manager- Rite Aid Plymouth Adjunct Professor-Plymouth State University Health and Human Performance/Pharmacology Advisory Council- Plymouth State University Nursing Program Plymouth School Board Chairman Commissioner, New Hampshire Board of Pharmacy, past 6 years 2

Compliance/Board Rules Issues Current Legislative Initiatives Prescription Drug Monitoring Program 3

4

What can you change on a CII script? Current federal law prohibits changes to a schedule II prescription. August 2011, DEA guidance letter to NABP allowed certain situations where pharmacist can use professional judgement after contacting prescriber without needing a new hardcopy RX. Deferred to state BOP, developed policy statement effective January 2012 5

Changes that CAN be made BUT: must contact prescriber to change the following: Patients address Drug strength Drug quantity Directions for use Dosage form Document changes on RX, date and time of consultation with provider 6

What you CANNOT change on RX: Patients name Controlled substance(s) prescribed Prescribers signature do not fill until date 7

Question. Can you change hydrocodone/apap 5/300mg to hydrocodone /APAP 5/325mg if you do not have in stock etc?? 8

9

2015 Board Compliance Audit What the Board is not doing.. Holding pharmacists and permit holders accountable for the rules 10

Ph 404.03 Non-sterile Pharmaceutical Compounding. (a) Compliance with USP 795 and all applicable USP chapters related to non-sterile compounding shall be followed. (b) There are 3 general categories of non-sterile compounding described in this section that require different levels of experience, training and physical facilities. The 3 categories shall be: (1) Simple compounding - Reconstituting (2) Moderate compounding mixing 2 or more manufactured creams, Magic mouth wash, etc (3) Complex compounding preparations that require specialized trainings 11

404.03 (d) (d) The compounding area shall adhere to the general principles listed in USP 795 guidelines including but not limited to: (1) Adequate space specifically designated for compounding and storage of equipment and materials; (2) Be clean, orderly, and properly maintained; (3) Easily accessible hand washing, hot and cold water, soap or detergent, and an air-drier or single-use towels must be present; (4) Be located in a separate area from sterile compounding area; (5) Purified water shall be used for compounding non-sterile drug preparations when formulations indicate the inclusion of water 12

(f) Component Selection, Handling and Storage shall be subject to the following requirements: (3) Components for compounding shall be properly labeled with lot numbers and expiration dates. If a component is transferred from the original container to a new container, the new container shall be labeled with the component name, original supplier, lot or control number, transfer date, and expiration date and shall provide integrity that it is equal to or better than the original container; (4) For components that do not have expiration dates assigned by the manufacturer or supplier the compounder shall label the container with the date of receipt and assign a conservative expiration date not to exceed 3 years after receipt; 13

PART Ph 501 CODE OF ETHICS Ph 501.01 Standards of Conduct. (a) The ethical standards set forth in this part shall bind all licensees, and violation of any such standard shall be a basis for the imposition of disciplinary sanctions. (12) Maintain a sanitary and orderly prescription department which is fully equipped and stocked to meet the needs of the community; 14

Ph 702.01 Area, Space and Fixtures. (a) Pharmaceuticals, library and equipment shall be housed in a well-lit and ventilated room or department with clean and sanitary surroundings devoted primarily to the preparation and dispensing of prescriptions. Who is responsible???? The pharmacist in charge, and: d) The corporate entity or permit holder shall be responsible for the following: Written policies and procedures for the procurement, storage, compounding and dispensing of drugs; 15

PH 700 s - pharmacy practice Has everyone taken a PIC exam????.a little history 16

Expired rule.. Ph 306.05 Amend Permit Application Contents and Where Filed. (a) Each applicant for amending a pharmacy permit for the purpose of a change of pharmacist-in charge, a pharmacy name change or a licensed area change shall make application on an Amend-A-Pharmacy Form Ph A-4. Legislative review stated the Board of Pharmacy does not have the authority under current law/legislation to amend a permit Should have been removed at last update. 17

JLCAR Joint Legislative Committee on Administrative Rules 18

Ph 305.01 Original Permit Conference (a) In addition to all requirements set forth in the statutes and elsewhere in this chapter, each applicant applying for a permit to operate a pharmacy in New Hampshire shall appear before the board for an informal conference to review the responsibilities of the pharmacist-in-charge and to determine if, in the opinion of the board, issuance of the permit would be in the best interest of public health and welfare. (b) If the owner is not the pharmacist-in-charge, then the owner or an officer of the corporation, or the district manager, as well as the anticipated pharmacist-incharge shall appear before the board. 19

What gives the board the authority to require a pharmacist-in-charge exam? RSA 318:5(a) give the board the authority to determine: The procedure of any license Qualifications of the applicant in addition to those requirements set in statute, Design and content, and How an applicant shall be examined. 20

So why a PIC exam??? It is important to make sure PIC s are aware of their obligations and have a solid understanding of the statue and rules There were two choices: 1. Have the pharmacist in charge come before the board every time a license is granted (new or transferred) to attest to their ability to properly manage a pharmacy and verbally answer as to their ability to uphold the rules and regulations 2. Take a written exam to attest to their knowledge of the rules and regulations. Much easier to be available to take over a pharmacy in short notice. Current board rules get in the way of this plan. What we see come before the board and during board inspections are the same procedural issues and violations of existing rules with many happening countless times. 21

Ph 305.01 PharmacyPermit Conference. (a) In addition to all requirements set forth in the statutes and elsewhere in this chapter, each applicant applying for a permit to operate a pharmacy in New Hampshire shall appear before the board for an informal to review the responsibilities of the pharmacist-in-charge and permit holder. (b) If the owner is not the pharmacist-in-charge, then the owner or an officer of the corporation, or the district manager, as well as the anticipated pharmacist-in-charge shall appear before the board. 22

Board still decided to keep PIC exam to make sure we all know the rules 23

FAQ s.where and when? Test developed and continually updated. Question pool of 150 questions developed by board staff 25 multiple choice, true/false and select all that apply questions on New Hampshire pharmacy law Available every day at board office by appointment 24

Ph 704.13 Termination of Pharmacist-in- Charge - Inventory. Whenever a pharmacist-in-charge shall cease performing that function in a pharmacy, the new pharmacist-in-charge shall, within 3 days, cause to be completed a written inventory of all controlled substances located in that pharmacy. The record of that inventory shall be retained in the pharmacy for a minimum of 2 years. 25

QUESTION??? Three (3) days from time pharmacist in charge becomes PIC and starts working or 3 days from time board approves pharmacist in charge??????? 26

Ph703 Records and Reports (a) The requirements of Ph 703 shall be in addition to all record keeping and reporting requirements contained in all federal and state rules and regulations. (b) Hard copies of prescription records and reports shall not be required to be maintained if they can be reproduced on demand with the exception of Schedule II V controlled substance prescriptions not presented in electronic format. (c) Hardcopy prescriptions for Schedule II V controlled substances shall be kept on file for 4 years. 27

703.04 Controlled Drug Losses a. 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. 28

703.04 continued. (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. 29

QUESTION???? Then why are pharmacies still sending the Board paperwork when less than 15 doses are lost???????? 30

704.03 Transmission of Prescription Drug order by provider A Review (4) A facsimile prescription for a schedule II controlled substance shall not be accepted as an original written prescription except in circumstances when: a. A prescription prepared in accordance with RSA 318-B:9, III and IV, and issued for a schedule II substance, as defined in RSA 318-B:1-b, to be compounded for the direct administration to a patient in a private residence, long-term care facility, or hospice setting, by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be electronically transmitted, by the practitioner or the practitioner s designated agent to the dispensing pharmacy. The printed copy of the transmission shall serve as the original written prescription and shall be maintained in accordance with the provisions of RSA 318-B:9, I; 31

704.04 Transfer of Prescriptions (j) New or on-hold prescription orders for prescription orders other than control substances may be transferred to another pharmacy provided that a copy of the original prescription or electronic transmission is provided to the pharmacy accepting the transfer. (k) New or on-hold prescription orders for controlled substances shall not be transferred to another pharmacy. 32

704.11 Pharmacist in Charge/Corporate Entity Requirements/Duties A. Pharmacists looking to serve as a Pharmacist-in-Charge (PIC) shall: 1. Have worked as a pharmacist for a minimum of 2 years post-graduation, and 2. 3. Complete and pass with a minimum of 80% an exam designed by the board to assess the knowledge of the candidate in regard to their responsibilities as PIC. Work a minimum of 20 hours per week at the location where he/she serves as PIC except when absent due to scheduled vacation or other authorized leave. 33

704.11 continued (d) The corporate entity or permit holder shall be responsible for the following: 4. Establishing procedures and policies to ensure the security of the pharmacy department when a pharmacist is working alone and needs to leave the licensed area for counselling, immunizations, lunch or rest room breaks; 6. Assuming all the responsibilities of the pharmacist in charge in an interim period when the pharmacist in charge has been vacated unexpectedly; and 7. Supplying adequate staffing to assist the board of pharmacy during scheduled routine inspections to assist with the retrieval of records when hard copy records are not maintained 34

Rest breaks 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 for a period of 30 minutes without closing the pharmacy and removing support personnel from the pharmacy, provided that the pharmacist reasonably believes that the security of the prescription drugs will be maintained in the pharmacist s absence 35

Rest Breaks continued (d) The corporate entity or permit holder shall be responsible for the following: 4. Establishing procedures and policies to ensure the security of the pharmacy department when a pharmacist is working alone and needs to leave the licensed area for counselling, immunizations, lunch or rest room breaks; 6. Assuming all the responsibilities of the pharmacist in charge in an interim period when the pharmacist in charge has been vacated unexpectedly; and 7. Supplying adequate staffing to assist the board of pharmacy during scheduled routine inspections to assist with the retrieval of records when hard copy records are not maintained 36

Question??? In the interim period between when a pharmacist-in-charge leaves a pharmacy and when the Board approves the new PIC, who is responsible for the pharmacy? 37

704.15 Prescription Refill-Interim Supply Ph 704.15 Prescription Refill - Interim Supply. A pharmacist may refill a prescription drug order, including controlled substances listed in Schedules III, IV and V, without the authorization of the prescribing practitioner, provided that: (a) A failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering; (b) The pharmacist is unable to contact the practitioner due to: (1) A natural or man-made disaster has occurred which prohibits the pharmacist from being able to contact the practitioner; or (2) The practitioner s office being closed without a practitioner on call; 38

704.15 continued (c) The quantity of prescription drug dispensed does not exceed a 30 day supply for maintenance medications; (d) The pharmacist informs the patient or the patient's agent at the time of dispensing that the interim supply shall be final and that authorization by the practitioner shall be required for future refills; and (e) The pharmacist shall inform the prescribing practitioner of the limited emergency supply, provided to the patient, at the earliest reasonable time; (f) The pharmacists exercises professional judgement in refilling the prescription drug order. 39

706.0 Pharmacetical Care Standards (c) The pharmacist shall make a reasonable effort to obtain from the patient or the patient's agent, and record, any known: (1) Allergies; (2) Drug reactions; (3) Idiosyncrasies; and (4) Usage of other drugs, including over-the-counter drugs, or medical devices currently being used by the patient. No longer need to obtain disease states 2015 legislative audit Still required by OBRA90! 40

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706.03 Patient Counseling (a) Pharmacists shall be required to make a reasonable attempt to counsel the patient or patient s caregiver in person or by telephone when dispensing the first fill of a new prescription in the following situations: (1) Prescriptions for patients under the age of 13; (2) Concentrated medications; or (3) Anticoagulant/antiplatelet medications; (4) Endocrine medications; and (5) Anti-infective medications. (b) Pharmacists, pharmacy interns or New Hampshire certified technicians shall document that counseling was given (c) In situations where there is not direct contact with the patient or caregiver including but not limited to nursing homes, assisted living or prisons, supplemental printed information shall be provided. 42

Proposed addition to counseling rules: All class II medications Specifically opioid containing drugs!! Medications considered having a high addiction potential 43

PART Ph 802 DEFINITIONS Ph 802.01 Definitions. Except where the context makes another meaning manifest, the following definitions shall apply: (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. 44

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 45

Board approved data entry module..supervision.. 46

Certified Pharmacy Technicians New Hampshire Certified pharmacy technicians Completed 600 hours training within pharmacy under direction of licensed pharmacist Passed a national certification exam A New Hampshire Certified technician with sterile compounding duties must pass an exam on sterile compounding 47

Ph 807.01 Responsibilities and Duties. Persons subject to these rules shall comply with the following: (a) It shall be the responsibility of the pharmacist-in-charge to identify pharmacy technicians and to assure that such persons are registered with the board as pharmacy technicians within 30 days of employment. (c) The pharmacist in charge shall determine the duties of each pharmacy technician based upon the needs of the pharmacy. Pharmacy technicians shall be limited to performing tasks in the preparation of prescription and non-prescription drugs and devices and to provide nonjudgmental technical support services within their respective level (d) The pharmacist on duty or the supervising pharmacist may further limit the duties of a pharmacy technician. 48

Ph807.02 Registered Pharmacy Technician duties. Registered pharmacy technician s duties shall include: a.the processing of refill request orders; b. The retrieval of prescription files, patient files and profiles and other such records pertaining to the practice of pharmacy; c. The counting, weighing, measuring, pouring and reconstitution of prescription medication or stock legend drugs and controlled substances; and d. The data entry of prescription orders without direct supervision providing they annually complete a board approved data entry module.. 49

Ph807.03 Registered Certified Pharmacy Technicians duties. Registered certified pharmacy technicians duties include: a. Accepting a new oral telephone order; b. Accepting an oral refill authorization from a Provider; c. Communicating a prescription transfer for a non-control medication to or from another pharmacy that does not maintain a common database; d. 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; e. Performing the data entry of a prescription or medication order into the computer without supervision; f. The task of reducing to writing a prescription left on a recording or message line. Prescription order can only be deleted by pharmacist on duty. 50

g. May prepare or compound sterile and non-sterile compounds after completing board approved compound training h. Stocking or replenishing of an automated dispensing machine or other stock location. A certified pharmacy technician may check the medications pulled by a pharmacy technician or certified pharmacy technician against the delivery report prior to the refill of the automated dispensing machine or other stock location. A licensed health professional shall check the medication before administering to the patient. The facility shall employ bar coding, rfid, or another form of electronic bedside verification. 51

Pharmacist in Charge responsibilities-technicians Licensed with board within 30 days and renewed annually Taken data entry module yearly if entering prescription data into computer Completed 10 CEU s if New Hampshire Certified Technician 1 CEU s in didactic setting 1 CEU s on error prevention or patient safety Completed sterile compounding requirements 2 CEU s in sterile compounding 52

Advanced Practice Pharmacy Technician 53

4. STATEMENT FROM PHARMACIST-IN-CHARGE FOR APPLICANTS FOR NH CERTIFIED PHARMACY TECHNICIAN STATUS I,, pharmacist-in-charge for Printed Name of Pharmacist-In-Charge Name & Address of Pharmacy have verified and confirm to the Board that the Pharmacy Technician employed at the above pharmacy has completed the required 600 hours of training under the direction of a pharmacist as required per Ph 803.01(e)(1) and if this pharmacy technician s duties include compounding of sterile or non-sterile prescription products that they have completed a Board approved training program on the safe compounding of medications. Certified By:. Date: Signature of Pharmacist-In-Charge 54

PH 1100 Collaborative Pharmacy Practice Ph 1101.01 Purpose. The purpose of this chapter is to implement and regulate collaborative pharmacy practice as a means to make the provision of certain aspects of health care more efficient, less costly, and provided in a more timely manner. Ph 1101.02 Scope. These rules shall regulate collaborative pharmacy practice only in the following institutions where the practice is permitted pursuant to RSA 318:16-a, III(a) (d), namely: (a) Hospitals; (b) Long-term care facilities; (c) Licensed inpatient or outpatient hospice settings; and (d) Ambulatory care clinics with onsite supervision by the attending practitioner and with a collaborating pharmacist who has no connection to any onsite retail pharmacy. 55

Proposed new rules (a) A pharmacist who seeks to engage in collaborative practice shall [meet the requirements of]: (c) Have earned a Pharm.D. degree or completed 3 years of institutional clinical experience as a licensed pharmacist (1) [RSA 318:16-a, I(a) relative to licensure in New Hampshire] Hold an unrestricted and current license to practice as a pharmacist in New Hampshire; (2) [RSA 318:16-a, I(b) relative to professional liability insurance coverage] Hold and maintain at least $1,000,000.00 of professional liability insurance that covers services performed under a signed, written collaborative agreement; 56

Ph 1102.04 Dedicated time means scheduled, uninterrupted time that a pharmacist will need to exclusively perform the duties and responsibilities outlined in the collaborative agreement. This time shall not be used perform any other functions or responsibilities, such as dispensing functions, support functions, product verification, quality assurance, or answering the phone 57

318:16-a Standards for Collaborative Pharmacy Practice. I. For a pharmacist to participate in a collaborative pharmacy practice agreement, the pharmacist shall: (3) [RSA 318:16-a, I(c) relative to education or experience] Have the knowledge base to properly perform the duties in the collaborative agreement, which shall include but not be limited to: a. Associated disease states; b. Relevant laboratory tests; c. Adverse events; d. Drug and food interactions; and E. Safety and efficacy of related drugs; and (4) [RSA 318:16-a, I(d) relative to completion of continuing education in any of the subjects or activities listed in RSA 318:1, XXVIII, (a) (i)] Depending on the complexity of services to be provided by the pharmacist the Board may require additional credentials and training to demonstrate knowledge and experience to provide the services as outlined in the collaborative agreement; and 58

Ph 704.12 Termination of Pharmacist-in-Charge Notice. Whenever a pharmacist-in-charge shall cease performing that function, that pharmacist-in-charge shall notify the board in writing of the date upon which the cessation of that function is effective. That pharmacist-in-charge shall remain responsible for compliance, in the pharmacy in which he or she was the pharmacist-in-charge, with all pharmacy related statutes and rules until the effective date of termination. 59

Ph 704.13 Termination of Pharmacist-in-Charge - Inventory. Whenever a pharmacist-in-charge shall cease performing that function in a pharmacy, the new pharmacist-in-charge shall, within 3 days, cause to be completed a written inventory of all controlled substances located in that pharmacy. The record of that inventory shall be retained in the pharmacy for a minimum of 2 years. Who does an inventory when pharmacist-incharge leaves suddenly??? 60

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Vaccines 318:1 Definitions. In this chapter: I. "Administer'' means an act whereby a single dose of a drug is instilled into the body of, applied to the body of, or otherwise given to a person or animal for immediate consumption or use. Ph 1302.01 Administer means administer as defined in RSA 318:1, I, namely, an act whereby a single dose of a drug is instilled into the body of, applied to the body of, or otherwise given to a person or animal for immediate consumption or use. 62

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 vaccines to individuals 18 years of age or older, provided all of the criteria in this section have been met. The pharmacist shall: 63

Michael Bullek 34 Parker St. Plymouth, N.H. 03264 603-536-4932 -------------------------------------------------------------- Hepatitis-B series 1 dose Dispense and administer 1 dose by injection once a month for three months. Dr. Tom Brady 2 refills 64

Walgreens-Declaritory Ruling Contractual issue with military vaccine administration in pharmacies legislative intent 65

C.E requirements Ph 403.02 Renewal Requirements. (d) All pharmacists licensed in New Hampshire shall acquire 1.5 CEU's during the 12 months immediately preceding the license renewal date of January 1st. At least 0.5 CEU's shall be earned in a live setting. (e) Continuing education credits shall not be recognized for any repeat program attended or completed. Repeat programs shall be identified as any program, live or correspondence, which carries the same ACPE, CME or any board of pharmacy program identification number. (g) Not less than 10% of the registrants shall be randomly selected each year by the board for determinations of compliance with Ph 403.02 Submit ORIGINAL certificates or copy of NABP /CPE monitor 66

SB 150 Relative to pharmacy interns administration of vaccines. Passed House and Senate, awaiting Governors signature 318:16-b Pharmacist administration of vaccines or pharmacy intern under the direct supervision of an immunizing pharmacist. Flu vaccines per protocol Pneumococcal and varicella zoster age 18 and older. 67

SB65 Relative to vaccines administered by pharmacists Passed/adopted House and Senate, awaiting Governors signature. 318:16-b A pharmacist may administer..hepatitis A, hepatitis B, Tdap, MMR, and meningococcal vaccines to individuals 18 year and older. Effective date January 1, 2018 68

SB64 Establishing a committee to study medication synchronization. Passed/adopted by House and Senate, signed by Governor The committee shall study medication synchronization as a tool which can improve adherence to medications when patients on regular chronic medication Committee report due on or before November 1, 2017 BARRIERS???? 69

HB 550-FN Establishing a controlled drug scientific review board House- inexpedient to legislate 70

HB 469 Establishing a continuous quality improvement program for pharmacies Passed/adopted by House Passed Senate Amendment brought by NACDS to take QA program out of pharmacies Board does not support this amendment, kills concept of bill. Compromise reached if already reporting to central clearing house. 71

SB264 Establishing a commission to study allowing pharmacists to prescribe or make available via protocol oral contraceptives and certain related medications Passed/adopted in House and Senate with amendment, Signed by Governor Board goal in this commission is to work towards provider status. 72

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HB 291-FN Amendment Removing veterinarians from the requirement of adopting rules for prescribing opioids. Amendment to add funding for PDMP program in sum of $115,000 Also plan for Funding required. The administrator of the controlled drug prescription health and safety program shall develop a plan for sustainable funding which shall not include monies from the general fund by November 1 st, 2017. 74

Where is new funding going to come from? Cannot use public funding for program by statute. 75

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HB 455-FN Prohibits pharmacy benefit managers from requiring providers to attain accreditation, credentialing, or licensing other than by the pharmacy board or other state or federal entity. House: Passed/adopted Senate: in committee This bill requires everyone s attention!! Credentialing costs from $2,000 to $35,000 per pharmacy! 77

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NH Prescription Drug Monitoring Program 79

What is the Prescription Drug Monitoring Program (NH PDMP)? The official title of the NH PDMP is: New Hampshire Controlled Drug Prescription Health and Safety Program RSA 318-B 31-38 (Prescription Drug Monitoring Program PDMP). The NH PDMP became operational in October 2014. It is a web-based data system that contains information on controlled prescription medications (Schedules II-IV) dispensed by New Hampshire licensed retail pharmacies and other dispensers.. It supports legitimate medical use of controlled substances while limiting drug misuse, abuse and diversion. It is intended to help prescribers avoid drug interactions, identify possible substance abuse disorders and drug seeking behaviors. 80

The Goals of the NH PDMP Develop and Implement an Essential Tool to: Ensure Access to Controlled Substances for Legitimate Medical Purposes Provide Education & Information Inform Public Health Initiatives Identify Early Intervention & Prevention 81

PDMP By Operating State Agency Type PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC CA WA OR ID NV UT MT CO ND NE OK MN PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC AZ WY NM SD PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC LA AK TX KS PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC FL Pharmacy Boards (20) IA *MO AR WI IL MS IN TN AL MI OH KY GA WV VA SC VT ME NY RI CT PA NJ NC DC NH MA DE MD PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC Department of Health (16) PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP Law TTAC Enforcement PDMP TTAC (5) PDMP TTAC HI Professional Licensing Agency (6) PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC GU Substance Abuse Agency (3) PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC PDMP TTAC Consumer Protection Agency (1) Research is current as of December 16, 2016 *Missouri does not have PDMP legislation

The Prescription Drug Monitoring Program has been viewed as a key component by the Governor and the legislature in stemming & battling the opioid crisis in New Hampshire June 2015 Passage SB 31 Amended Technical Changes January 2016 Passage SB 576 FN-A June 2016 Passage SB 522 (Funding to PDMP) June 2016 Passage HB1423 (mandated use expansion) 83

Who Puts in the Data? Dispenser means a person or entity who is lawfully authorized to deliver a schedule II-IV controlled substance, but does not include: (a) A licensed hospital pharmacy that dispenses less than a 48-hour supply of a schedule II-IV controlled substance from a hospital emergency department or that dispenses for administration in the hospital; (b) A practitioner, or other authorized person who administers such a substance; [or] (c) A wholesale distributor of a schedule II-IV controlled substance or its analog; (d) A prescriber who dispenses less than a 48-hour supply of a schedule II-IV controlled substance from a hospital emergency department to a patient; or (e) A veterinarian who dispenses less than a 48-hour supply of a schedule II-IV controlled substance to a patient. 84

A RISING STATE CRISIS Annual Trends: Drug overdose deaths are projected to increase by 9% from 2015 to 2016. In 2016 Hillsborough County had the highest suspected drug use resulting in overdose deaths per capita at 4.77 deaths Per 10,000 population. Strafford County had the second highest suspected drug use resulting in overdose deaths per capita at 4.47 deaths per 10,000 population. The age group with the largest number of drug overdose deaths is 30-39 which represents 31% of all overdose deaths for 2016. Source: Office of the Chief Medical Examiner 85

A RISING STATE CRISIS Annual Trends: Opioid related ED visits increased by 28% from February March 2017. In March residents from Hillsborough County had the most opioid related ED visits per capita with 6.75 visits per 10,000 population. Merrimack County had the second highest number of opioid related ED visits per capita with 6.29 visits per 10,000 population. The age group with the largest number of opioid Related ED visits is 20-29 which represents 38% of all opioid related ED visits for March. Source: Office of the Chief Medical Examiner 86

WHERE DRUGS ARE OBTAINED SAMSHA 87

TOP TEN OPIOIDS DISPENSED IN NH June 2016 (9 months) February 2017 Drug Code Rx Count Qty Dispensed Days of Supply Drug Code Rx Count Qty Dispensed Days of Supply OXYCODONE HCL 17,647 1,422,772 296,061 HYDROCODONE- ACETAMINOPHEN 16,275 817,024 204,876 TRAMADOL HCL 15,886 1,243,911 309,403 OXYCODONE HCL - ACETAMINOPHEN 11,679 572,663 143,414 OXYCONTIN 3,179 181,949 79,336 MORPHINE SULFATE ER ACETAMINOPHEN- CODEINE 3,053 178,949 78,740 2,899 106,192 27,122 FENTANYL 2,786 26,214 69,336 HYDROMORPHONE HCL 2,476 156,257 29,836 METHADONE HCL 2,342 276,456 56,184 TOTAL 78,222 4,982,386 1,294,308 OXYCODONE HCL TRAMADOL HCL HYDROCONE- ACETOMINOPHEN MORPHINE SULFATE BUPHENORPHINE HCL FENTANYL BUPHENORPHINE- NALOXONE HCL OXYCODONE HCL - ACETOMINOPHEN HYDROMORPHONE HCL ACETAMINOPHIN- CODEINE 18,189 1,392,782 330,723 12,868 1,009,790 257,275 12,332 649,285 165,283 9,925 222,649 122,601 8,912 469,425 119,644 4,685 263,315 94,122 3,425 96,133 43,286 2,283 21,331 56,570 2,198 139,750 29,983 2,149 78,842 20,275 TOTAL 76,966 4,343,302 1,239,762 88

Count of Rx Top 3 Stimulants Reported to NH PDMP 70,000 60,000 50,000 40,000 30,000 20,000 10,000 - DEXTROAMPHETAMINE/AMPHETA MINE METHYLPHENIDATE HCL LISDEXAMFETAMINE DIMESYLATE 2015_Q3 54,239 30,979 15,499 2015_Q4 56,918 33,307 16,703 2016_Q1 57,674 33,187 16,566 2016_Q2 59,507 33,368 16,327 2016_Q3 60,125 32,297 15,889 2016_Q4 61,324 33,902 17,000 89

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Total Number of Patients Meeting or Exceeding Prescriber/Dispenser Threshold for Schedule II, III and IV Prescriptions by Quarter Schedule II 5 + Prescribers and 5+ Pharmacies 10+ Prescribers and 10+ Pharmacies Oct-Dec 14 Jan-Mar 15 Apr-Jun 15 Jul-Sept 15 Oct-Dec 15 Jan- Mar 16 Apr-Jun 16 Jul-Sept 16 Oct-Dec 16 27 26 25 35 11 6 12 12 8 0 0 0 0 0 0 0 0 0 0 0 Jan-Mar 17 Schedule III 5 + Prescribers and 5+ Pharmacies 10+ Prescribers and 10+ Pharmacies Schedule IV 5 + Prescribers and 5+ Pharmacies 10+ Prescribers and 10+ Pharmacies Oct-Dec 14 Jan-Mar 15 Apr-Jun 15 Jul-Sept 15 Oct-Dec 15 Jan- Mar 16 Apr-Jun 16 Jul-Sept 16 Oct-Dec 16 4 5 4 4 1 3 0 2 1 2 0 0 0 0 0 0 0 0 0 0 Oct-Dec 14 Jan-Mar 15 Apr-Jun 15 Jul-Sept 15 Oct-Dec 15 Jan- Mar 16 Apr-Jun 16 Jul-Sept 16 Oct-Dec 16 25 27 21 22 17 11 8 11 5 13 0 0 0 0 0 0 0 0 0 0 Jan-Mar 17 Jan-Mar 17 TOTAL Schedule II,III,IV Oct-Dec 14 Jan-Mar 15 Apr-Jun 15 Jul-Sept 15 Oct-Dec 15 Jan- Mar 16 Apr-Jun 16 Jul-Sept 16 Oct-Dec 16 Jan-Mar 17 5 + Prescribers and 5+ Pharmacies 10+ Prescribers and 10+ Pharmacies 56 58 50 61 29 20 20 25 14 15 0 0 0 0 0 0 0 0 0 0 91

Questions or comments??? 92

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