DPH/DHHS CDC grants State grant over the next five years through a cooperative agreement with The Centers for Disease Control and Prevention (CDC) titled “Improving the Health of Americans through Prevention and Management of Diabetes and Heart Disease and Stroke (CDCRFA-DP18-1815 )”. Only state to receive this grant where pharmacists are participating as primary professional 26
February 25- May 2, 2019 Overview: 34 question, anonymous, online survey developed in partnership between: • NH Division of Public Health Services • NH Board of Pharmacy • NH Pharmacy Association • NH Society of Health-Systems Pharmacists 728 Responses (28% response rate): including 24 retired or non-practicing pharmacists. Results presented include only responses from currently licensed NH pharmacists (non-retired).
February 25- May 2, 2019 Purpose: 1. Define Medication Therapy Management (MTM), Diabetes Self-Management Education Support (DSMES), and Collaborative Practice Agreement (CPA) for practicing pharmacists 2. Collect anonymous, baseline data to understand awareness of, current integration of, and needs for integration of MTM, DSMES and CPA directly from pharmacists licensed and practicing in NH. 3. Determine areas where more outreach and/or continuing education and training are needed. 4. Gather data needed to report on performance measures required by CDC grant related to increasing engagement of pharmacists in the provision of MTM or DSMES for people with diabetes (i.e. number of pharmacy locations/pharmacists using patient care processes that promote medication management or DSMES for people with diabetes
February 25- May 2, 2019 Funding for this survey came through a five-year cooperative agreement with the Centers for Disease Control and Prevention (CDC) titled Improving the Health of Americans through Prevention and Management of Diabetes and Heart Disease and Stroke (CDCRFA-DP18-1815). Surveys, like the one, provide insight on the most effective areas to allocate CDC funding toward building awareness of and successfully integrating MTM, DSMES, and CPA in pharmacy practices across the state.
Demographics of Survey Respondents Pharmacists ’ Tit Phar itles (n (n=699) Current Practice Settin Cur ing (n (n=717) Pharmacy Supervisor / Manager / Director 30% 30% Clinical Pharmacist 27% 27% Operations Pharmacist 26% 26% Staff / Retail / Informatics Pharmacist 14% 14% Pharmacist Consultant 2% 2% Educator / Professor of Pharmacy 1% 1% Phar Pharmacists ’ Yea ears s in Practice (n (n=699)
Pharmacists’ MTM Awareness 715 individuals responded to their level of awareness of their ability to provide Medication Therapy Management (MTM) services to patients.* 79% reported being aware of their ability to practice MTM. Of the 5% who reported “very little” or “no” awareness, the majority of those respondents represented Home Health Care, Community Chain or Hospital / Health Systems. * MTM as defined by the American Pharmacists Association
MTM in Practice 686 pharmacists reported the frequency in which they practice MTM defined as: • Provision of information (verbal, online or • Administration of medication therapy (not written) including referrals to support including immunizations) services and resources designed to enhance • Initiation of medication therapy patient adherence with his/her therapeutic • Formulation of a medication treatment plan regimens • Coordination and integration of medication • Monitoring and evaluation of the patient’s therapy management services within the response to therapy, including safety and broader health care management services effectiveness being provided to the patient • Performing or obtaining necessary • Promotion of self-management and lifestyle assessments of the patient’s health status modification for high blood pressure and • Performing a comprehensive medication high blood cholesterol review to identify, resolve, and prevent • Modification of medication therapy medication-related problems, including adverse drug events 61% report they “Often” or “Always” provide MTM in the form of edu education and and tra raining (v (verbal, , onlin online, , or or writ ritten) des desig igned to o enh nhance pat patient und understandin ing and and appropriate use appr use of of hi his/h /her medications. s. Other MTM activities were reported to be rarely if ever implemented by pharmacists.
MTM TM in in Practic ice (c (cont.) .) Of the 61% who provide education and training (verbal, online, or written) designed to enhance patient understanding and appropriate use of his/her medications :
Ba Barri riers to Practic icin ing MTM TM Despite the high level of awareness of MTM in pharmacy practice, there remains a low level of MTM implementation across pharmacy types. To understand why this may be, respondents identified barriers to incorporating MTM in their practices. Top-ranked barriers include: 61% Lack in staffing capacity (n=350) 61% 54% 54% Difficulty in integrating MTM in to current workflow (n=312) 50% Lack in flexibility with time spent dispensing medications versus 50% counseling patients (n=287) 30% Lack of private / consultation space in practice setting (n=172) 30% Obstacles to billing / collecting payment for services (n=172) 22% Lack in professional training / skill in providing MTM (n=124) 9% Lack in understanding of MTM services (n=53) 6% Lack of evidence to support MTM integration in my practice (n=36)
NH Pharmacist Survey Full Report: November 2019 More in- depth analysis will be provided and include pharmacists’ responses to their level of awareness, perceived importance, and current practice of Diabetes Self- Management Education and Support (DSMES) for patients with diabetes. Additional analysis of pharmacists’ awareness, perceived importance, and implementation of Collaborative Practice Agreements.
Quality Assurance: HB 469 and Ph1700 Establishing a continuous quality improvement program for pharmacies 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. 36
Quality Assurance: 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. 37
Quality Assurance: The Board will be looking for: Policy and procedures Meeting attendance Summary Starting September 2019, first meeting January 2020 38
Upcoming rules changes RENEWAL AND REPLACEMENT LICENSES Now on line registrations for renewals Will ask for additional information!! Biennial licensing CONTINUING EDUCATION REQUIREMENTS Addition of 2 credits Law Annual requirements 39
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. 40
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 (SB483) (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. 41
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!!!! 42
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!!!! (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. 43
703.04 – Controlled Drug Losses (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) 44
Control drug loss data 211 reports of Controlled Substances were reported lost in 2018 97/211 or 45.9 % of the C/S reported loss are opioid or synthetic opioid 91% of all stimulants that were C/S loss were BRAND NAME! 12 reports came from Hospitals 5.6% of the reports came from Hospitals 41.6% of the Hospital reports (5 of 12) came from Mary Hitchcock / Dartmouth 199 Reports came from community (retail) pharmacies 39.8% of the reports came from Rite-Aid 30% of the reports came from CVS 6.6 % of the reports came from Shaw’s / Osco 5.2% of the reports came from Walgreens 2.84% of the reports came from Omnicare 1.42% of the reports came from Hannaford 1.42 % of the reports came from Wal-Mart Still a lot of reporting of less than 15 dosage units!! 45
REASON FOR LOSS 41.22 % Unknown THIS WILL BE A RED FLAG!!!!! 30.33% Miscounting & Overfill 2.84 % C/S was thrown out 2.84 % Diversion 1.42% Armed Robbery DRUG CATEGORY LOSS Opioid CII 37.9% Stimulants CII 16.8% Benzodiazepines 15.8% Tramadol 4.32% 46
703.04 – Controlled Drug Losses NEW!!! On line drug loss reporting replace New Hampshire Control Drug Loss form Sign in with same information used for licensing Print and upload or use on line form to submit Testing currently underway Target date is January 1 st , 2019 47
Break Policy 48
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. 49
Break Policy How many of you take a 30 minute uninterrupted break? What are the barriers? How to we fix? 50
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. (c) Advanced practice pharmacy technician (HB463) new license approved by legislature this year. 51
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 52
Register Technician Duties Ph807.02 Registered Pharmacy Technician duties. (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. (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. 53
Ph 808.01 Certified Pharmacy Technician Qualifications. (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. Ph 805.01 Change in Registration Information for Registered Pharmacy Technicians. (a) The person to whom a pharmacy technician registration has been issued shall, within 15 days of a change of address or location of employment, notify the board of such changes. 54
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; (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 certified pharmacy technician with duties involving sterile and non-sterile compounding, shall complete a board approved training program before participating in those duties. 55
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. 56
Certified Technician Duties (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; (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. 57
Continuing Education-Certified Ph 810.02 Continuing Education Requirements for Certified Pharmacy Technicians. (a) Certified pharmacy technicians shall maintain their nationally certified status and stay up to date with all continuing education requirements such certification demands. (c) Certified pharmacy technicians with duties involving sterile and non-sterile compounding shall complete a minimum of 0.4 CEU’s in the area of compounding. (d) Not less than 10% of certified pharmacy technicians shall be randomly selected each year by the board for determinations of compliance. ???????? Issues here!! 58
Ph 1800: Advanced Practice Pharmacy Technicians (a) “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 - dose. 59
So…….what do you think a marriage of “central fill processing/workflow balancing” and advanced practice technicians is going to do? 60
Vaccines NOTE: You cannot administer tetanus vaccine just because it is included in Tdap!!! You cannot advertise a measles vaccine!! It is a combination product (MMR)!! You can administer hepatitis A and B combination products!! 61
Vaccines and standing orders Board notice of August 16 th , 2018 318:16-b Pharmacist Administration of Vaccines. – A pharmacist or pharmacy intern under the direct supervision of an immunizing pharmacist may administer influenza vaccines to the general public and a pharmacist or pharmacy intern under direct supervision of a immunizing 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 Pharmacists have the ability to administer vaccines, the statutes do not give us prescriptive authority. All vaccines must have a provider associated with the collaborative practice agreement, standing order or written/verbal prescription. Open for interpretation…………. 62
SB179-relative to pharmacy administration of vaccines Referenced adult immunization schedule of 11 vaccines Hib, HPV, TD added to current list Not requested by any pharmacy organizations? Board not in favor of adding any additional vaccines due to provider backlash over paperwork transmissions Referred for more study 63
How many have issues with vaccination quotas? Business issue vs. practice???? 64
Pharmacist “Report Cards” More good news from the audit ……..stated we needed to inspect “pharmacists” as well as “pharmacies”…..haven’t figured out how to do that yet…….leads us too; 65
Pharmacist credentialing Maintain file for each individual pharmacist All CE’s will be downloaded as part of this process, effective with 2020 licensing process. Should simplify the audit procedure We need correct data in system!! 318:26-a Change in Name, Employment, or Residence. – Any pharmacist or pharmacy technician who changes his or her name, place or status of employment, or residence shall notify the board in writing within 15 days . For failure to report such a change within 15 days, the board may suspend the pharmacist's license or the pharmacy technician's registration. Reinstatement shall be made only upon payment of a reasonable fee as established by the board. 66
Credentialing HB 591-FN and HB1746-FN 2018- Prohibited PBM’s from requiring accreditation of providers. Bills were defeated. A sunset clause was in place that was removed in 2019. Pharmacy board has all the information necessary for credentialing process. Will be required for insurance billing for contraceptives!!! Any future provider status billing!!! 67
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!! 68
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ETHICS
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Corresponding responsibility Time for a discussion……. ……….Where do we draw the line???? 72
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. 73
Two Pharmacy Chains Pay Civil Monetary Penalties to Resolve Alleged Violations of the Controlled Substances Act CONCORD - Two national pharmacy chains agreed to pay civil monetary penalties to resolve allegations that they violated the Controlled Substances Act by filling fraudulent prescriptions, United States Attorney Scott W. Murray announced today. “Pharmacies and health care professionals must comply with their legal obligations in order to ensure that controlled substances do not end up in the wrong hands,” said U.S. Attorney Murray. “When businesses or individuals fail to fulfill these obligations, drugs can be diverted into the black market or otherwise misused. We will not hesitate to use federal enforcement tools to ensure that members of the health care industry follow the law.” “DEA registrants like Osco and Rite Aid have a corresponding responsibility to dispense controlled substances in accordance with the Controlled Substances Act. When these responsibilities are not adhered to it allows for the diversion of prescription pain medication which contributes to the widespread abuse of opiates that are devastating our communities,” said DEA Special Agent in Charge Brian D. Boyle. “Today’s settlements demonstrate DEA’s commitment to improve public safety and public health in New Hampshire.” 74
Ethics Board receiving too many inquires and complaints from providers and patients Legislators threatening action…..current system not in best interests of patients Board meetings with stakeholders on pain issues 75
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. 76
Subutex-suboxone difference ?????reasons why so much being dispense?????? Cost? Allergies????? Remember………corresponding responsibility!!!! Buprenorphine investigations 77
Ethics Due Diligence DOCUMENT!!!!! What is in the best interest of the patient? 78
Provider issues-BOM meeting of September 2019…….. Scope of practice Questioning/refusing of prescriptions Buprenorphine SL tablets pain vs MAT Quantity dose 80
While we are on topic of what we do wrong…….. Who is dispensing syringes without an prescription??? Noted at August meeting of Governor's commission on alcohol and other drugs………2 out of 18 pharmacies in Manchester will not dispense without prescription…….. Pharmacists choice……… Board memo of Feb 13 th , 2018 concerning RSA 318:52 (c) ; sale of hyper dermic syringes and needles 81
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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. 83
Naloxone Naloxone survey results for DHHS Access better than anticipated Usage numbers poor 215 pharmacies responded to survey. Excellent response!!!!!! Available for free as part of state “hub and spoke” program 84
Veternarians Seeing issues with multiple visits to providers using different animal names. Buprenorphine and tramadol issues. Due diligence!!! Verify RX’s!!!! 85
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The case of cannabis….. CBD oil an issue………. Agriculture has control…..out of pharmacies hands…..at the moment…….. Much more to come on this topic…. 87
Legislative Issues Affecting Pharmacy from 2019 session HB 359 relative to warning labels on prescription drugs containing opiates. “red cap” bill” This bill requires any drug which contains an opiate dispensed by a health care provider or pharmacy to have an orange sticker on the cap or dispenser and a warning label regarding the risks of the drug. This bill also requires the governor's commission on alcohol and drug abuse prevention, treatment, and recovery to develop a handout on the risks of opioids and how to mitigate them for persons who are receiving prescriptions for opioids. HB615 Pharmacy “cleanup bill” This bill makes various changes to the regulation of pharmacies and pharmacists by the board of pharmacy, including procedures of the board, exceptions to possessing prescription drugs, license expirations and renewals, and establishing the licensure of drug distribution agents.
Legislation- discussion on PBM’s HB670-FN- relative to cost of prescription drugs HB703-FN – relative to providing notice of introduction of new high-cost prescription drugs HB671-FN -relative to PBM business practices, licensure and transparency. SB222-FN- relative to licensure of PBM’s. Others affecting impact on insurance premiums SB226-FN-relative to registration of pharmacy benefit managers, and reestablishing the commission to study greater transparency in pharmaceutical costs and drug rebate programs.
Legislation- contraceptives?? HB1822-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, DHMC OB/GYN department head to sign blanket order. Specific education requirements, will begin this winter. Don’t expect program until next year.
Changes proposed this session 4 Amend RSA 318:16-a by adding: (a) The commissioner shall employ a managed care model for administering the Medicaid program and its enrollees to provide for managed care services for all Medicaid populations throughout New Hampshire consistent with the provisions of 42 U.S.C. 1396u-2, …………pharmacy benefit management, provider network management, quality management, and customer services . The model shall reimburse pharmacists for cognitive services enumerated in RSA 126-A:3 III-a. 4 Amend RSA 318:16-a by adding: VII. Pharmacists dispensing hormonal contraceptives via standing order pursuant to RSA 318:47-l II and pharmacists dispensing smoking cessation therapy via standing order pursuant to RSA 318:47-m II shall be considered to be in a collaborative practice agreement with the physician or APRN who signed the standing order. 92
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Next legislative initiatives E-prescribing (associated with PDMP changes on who is required to register with program, and data sharing ) Medicaid provider status for contraceptive billing Addition of smoking cessation standing order to contraceptive bill Statute and rules cleanup RSA 318-B:9 III (f) Sale by Pharmacists. Partial fill of CII’s (2009) “no refills shall be authorized for controlled drugs in schedule II of the current chapter 21, Code of Federal Regulations” Will be others 318-B:7 Written Orders. – An official written order for any controlled drug in schedule II shall be signed in triplicate by the person giving said order or by his duly authorized agent. (1985) Will be more………. Insulin price protections and limits 94
318-B:9 Sale by Pharmacists 21 U.S.C. 829 – control substances act B (f) Partial fills of Schedule II control substances. 1. Partial fills- a prescription may be partially filled if; A. it is not prohibited by state law B. written in accordance with this subchapter C. partial fill requested by patient or practitioner who wrote the prescription D. total quantity dispensed does not exceed total prescribed Remaining portions A (1) may be filled; and A (2) shall be filled not later than 30 days after date the prescription is written. 95
Tele-pharmacy: Tele pharmacy rules will be developed in near future. Current rules proposal (Ph900 update): Pharmacist in charge of all pharmacies doing business in state to be licensed by the Board Pharmacist’s involved in clinical duties shall be licensed by the Board. (same as tele medicine rules) Where does tele-pharmacy lead us? 96
Telemedicine issue 329:1-d Telemedicine. – I. "Telemedicine" means the use of audio, video, or other electronic media for the purpose of diagnosis, consultation, or treatment. "Telemedicine" shall not include the use of audio-only telephone or facsimile. II. An out-of-state physician providing services by means of telemedicine shall be deemed to be in the practice of medicine and shall be required to be licensed under this chapter. This paragraph shall not apply to out-of-state physicians who provide consultation services pursuant to RSA 329:21, II. III. It shall be unlawful for any person to prescribe by means of telemedicine a controlled drug classified in schedule II through IV. IV. (a) The prescribing of a non-opioid controlled drug classified in schedule II through IV by means of telemedicine shall be limited to prescribers as defined in RSA 329:1-d, I and RSA 326- B:2, XII(a ), who are treating a patient with whom the prescriber has an in-person practitioner-patient relationship, for purposes of monitoring or follow-up care, or who are treating patients at a state designated community mental health center pursuant to RSA 135-C or at a Substance Abuse and Mental Health Services Administration (SAMHSA)-certified state opioid treatment program, and shall require an initial in- person exam by a practitioner licensed to prescribe the drug. Subsequent in-person exams shall be by a practitioner licensed to prescribe the drug at intervals appropriate for the patient, medical condition, and drug, but not less than annually. (b ) The prescribing of an opioid controlled drug classified in schedule II through IV by means of telemedicine shall be limited to prescribers as defined in RSA 329:1-d, I and RSA 326-B:2, XII(a), who are treating patients at a SAMHSA-certified state opioid treatment program. Such prescription authority shall require an initial in-person exam by a practitioner licensed to prescribe the drug and subsequent in-person exams shall be by a practitioner licensed to prescribe the drug at intervals appropriate for the patient, medical condition, and opioid, but not less than annually. Source. 2015, 246:6. 2016, 221:3, eff. Aug. 8, 2016.
DEA inspections………. Control drug prescription requirements for ALL prescriptions!!! III. Prescriptions issued by practitioners for controlled drugs shall be executed in clear, concise, readable form. Each prescription shall contain the following information and comply with the following requirements: (a) The full name and complete address of the patient or of the owner of the animal for which the drug is prescribed. (b) The day, month, and year the prescription is issued. (c) The name of the controlled drug prescribed. Only one controlled drug shall appear on a prescription blank. (d) The strength of the controlled drug prescribed. (e) The specific directions for use of the controlled drug by the patient. (f) No refills shall be authorized for controlled drugs in schedule II of the current chapter 21, Code of Federal Regulations. (g) The federal Drug Enforcement Administration registration number of the practitioner. (h) The practitioner shall manually or electronically sign the prescription on the date of issuance. (i) The practitioner's full name shall be printed, rubber stamped, or typewritten above or below the manual or electronic signature. 98
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