Michael D. Bullek BSP Rph. Commissioner, New Hampshire Board of Pharmacy

Transcription

1 Michael D. Bullek BSP Rph. Commissioner, New Hampshire Board of Pharmacy

2 Legislative changes PDMP program changes 503B outsourcing facilities Rules changes Ph800 review Ph300 Ph400 Ph700 Current issues What s next..

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4 CHAPTER Ph 800 PHARMACY TECHNICIANS Statutory Authority: RSA 318:5-a, X, XI PART Ph 801 PURPOSE AND SCOPE Ph Purpose and Scope. The provisions of this chapter shall apply to, and impose duties upon, all pharmacy technicians holding registrations issued by the board.

5 PART Ph 802 DEFINITIONS Ph 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.

6 Registered Pharmacy technician: All personnel working within the pharmacy are to be licensed as registered pharmacy technicians Cashiers Delivery personnel Billing/data entry Registered Pharmacy technicians with duties that include data entry of prescriptions without direct supervision Need to take an update annually of board approved competencies in data entry

7 Board approved data entry module Currently meeting to develop list of competencies Will include Pharmacy law How to read and interpret a prescription Directions, days supply etc. Basic pharmaceutical calculations

8 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

9 Ph 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.

10 Ph 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..

11 Ph 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.

12 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.

13 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 (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

14 PDMP program Requires all practitioners who prescribe but do not dispense schedule II-IV controlled substances shall register with the program as a prescriber Practitioners who dispense but do not prescribe schedule II-IV controlled substances shall register with the program as a dispenser unless exempted pursuant to RSA 318-B:31, IV and Practitioners who prescribe and dispense schedule II-IV controlled substances shall register with the program as both a prescriber and a dispenser unless exempted pursuant to RSA 318-B:31,IV

15 A practitioner means a physician, dentist, podiatrist, veterinarian, pharmacist or other person licensed or otherwise permitted to prescribe, dispense, or administer a controlled substance in the course of licensed professional practice.

16 A dispenser means a person who is lawfully authorized to deliver a schedule II-IV controlled substance, but does not include: 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 A practitioner, or other authorized person who administers such a substance, A wholesale distributor of a schedule II-IV controlled substance or its analog 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 A veterinarian who dispenses less than a 48 hour supply of a schedule II-IV controlled substance to a patient

17 Registration data: 2519 licensed pharmacists in state of NH 1018 registrations finalized (40%) 1155 pharmacists still need to register by licensed APRN in state of NH 1146 registrations finalized 750 nurse practitioners still need to register by veterinarians in state of NH 114 registrations finalized (13%) Registrations mandatory based on updated rules changes!!!!!

18 Major updating to current standards Increased scrutiny due to Massachusetts compounder issue

19 1987 Prescription Drug Manufacturing Act Put in place to control counterfeit products Required states to pass statues and rules requiring regulation of manufacturers, wholesalers and distributors Drug Quality and Safety Act Brought on by issues with New England Compounding Center (NECC). Created new entity outsourcing pharmacies or 503B facilities

20 Not traditional manufacturers by 1987 standards small manufacturers under the radar of FDA oversight mom and pop pharmacies that manufacture in small bulk quantities Not held to same standards as traditional manufacturers Point to remember: NH follows 1987 rules that state anyone selling more than 5% of there business wholesale (non patient specific) must license as a manufacturer, wholesaler or distributor

21 Board agreed to work with all stakeholders to create legislation to license 503B entities. First step: find a sponsor.. Second step: create draft legislation before Tuesday, December 9 th (legislative deadline for this session? Finish legislation by January 9 th 2015 Push for implementation date of June 30 th 2015

22 An act relative to licensure of outsourcing facilities by the pharmacy board. This bill establishes the requirement for licensure by the pharmacy board of outsourcing facilities operating pursuant to section 503B of the federal food, drug and cosmetic act.

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25 Everyone ready for a PIC exam????.a little history

26 Ph Amend Permit Application Contents and Where Filed. (a) Each applicant for amending a pharmacy permit for the purpose of a change of pharmacistin 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 rules to amend a permit Should have been removed at last update.

27 PART Ph 305 ORIGINAL PERMIT PROCEDURE Ph 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-in-charge shall appear before the board.

28 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.

29 So why a PIC exam??? What we see come before us at the board and during board inspections are the same procedural issues and violations of existing rules with many happening countless times. It is important to make sure PIC s are aware of their obligations and have a solid understanding of the statue and rules

30 So why a PIC exam??? There were two choices: 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 there ability to uphold the rules and regulations Various problems can occur with this 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.

31 FAQ s.where and when? Test under development Question pool of 150 questions developed by board members and staff 25 multiple choice questions on New Hampshire pharmacy law Available every day at board office Regional test sites to be administered by board members and staff

32 (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.

33 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.

34 (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.

35 (g) Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original prescription order, including refill orders for a schedule III, IV, or V controlled substances is correct shall be provided by: (1) A hard-copy printout of each day's controlled substance prescription order refill data which shall be verified, dated, and signed by each pharmacist who refilled such prescription orders; or (2) In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him and is correct as shown; (h) The hard-copy printout or log book referenced in (g) above shall be kept at the pharmacy, in a separate file, for a period of 4 years from the dispensing date;

36 (k) Each pharmacy using an automated data processing system shall maintain on file a hard copy of all controlled substance prescriptions in schedules II, III, IV and V, excluding electronic, preserving all information contained on the original written or oral prescription. Any computer generated material shall be affixed to the rear of the prescription, leaving the face of the prescription intact; and

37 (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; b. 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, for a resident of a longterm care facility 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; and

38 New language utilizing certified technicians and interns (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.

39 (a) Except as provided in Ph (b), no drug, prescription, device, sickroom supply or item of personal hygiene which is returned to the pharmacy shall be re-sold or re-dispensed after such item has been taken from the premises where sold, distributed or dispensed. Has left control of the pharmacist or pharmacy and is returned to the pharmacy shall be resold or redispensed after such item has been taken from the premises by the patient or the patient s representative, subject to the pharmacist s professional judgement. Example: eyedrops, inhalers

40 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. 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. 3. 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.

41 (d) The corporate entity or permit holder shall be responsible for the following: 1. Written policies and procedures for the procurement, storage, compounding and dispensing of drugs; 2. Ensuring that all staff pharmacists are familiar with and in compliance with the established policies and procedures; 3. Determining which security personnel will have keys and access to the pharmacy and inform the pharmacist in charge; 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; 5. Providing online access to the New Hampshire law book, medical reference material and other state and local sites for reference by their pharmacists; 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

42 Ph 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;

43 (c) The quantity of prescription drug dispensed does not 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.

44 (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

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46 (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 counselling 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.

47 Updating of rules Updating of collaborative practice rules

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