Administrator/Chief of Compliance New Hampshire Board of Pharmacy 1 - - PowerPoint PPT Presentation
Michael D. Bullek BSP R.Ph. Administrator/Chief of Compliance New Hampshire Board of Pharmacy 1 Todays discussion : New rules and rules changes Pharmacy practice and ethics Legislative issues Prescription Monitoring Program
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Michael D. Bullek BSP R.Ph. Administrator/Chief of Compliance New Hampshire Board of Pharmacy
New rules and rules changes Pharmacy practice and ethics Legislative issues Prescription Monitoring Program update
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Statement of Disclosure
I have nothing to declare
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Rules currently in legislative process Rules in Review Pending rules issues
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Have prescriptive authority for whole range of FDA
approved medications………
Formulary on Pharmacy Board website
DO NOT need a DEA or NPI number to
prescribe!!!!
Compliance required by statute to create inspection
rules………
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SB 377-FN (2018 Dental cleanup bill)
Relative to the regulation of dentists and dental
hygienists by the board of dental examiners.
316:13 (g)
The administration, prescription, and dispensing of a
fluoride supplement, topically applied fluoride and chlorhexidine gluconate oral rinse.
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HB615 Pharmacy cleanup bill 6. New Subparagraph; Dealing in or
Possessing Prescription Drugs; Dental
inserting after subparagraph (b) the following new subparagraph:
(c) Nothing in this section shall prohibit a
dental hygienist from possessing, administering, dispensing, or prescribing
fluoride, and chlorhexidine gluconate oral rinse pursuant to RSA 317-A:21-c, I(g).
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All CPE monitors and CE certificates not posted to
monitor shall be uploaded during pharmacists renewal
All demographic/employment updates/changes must
be submitted online using Board forms and process
Technicians can apply online for initial registrations
and reinstatements. Instructions posted on website. Pharmacists to follow shortly.
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SB376-FN Relative to the sale of certain cold
medications
Regulates the sale and possession of products
containing ephedrine and pseudoephedrine
Allows for sale, providing follows federal reporting
guidelines in any retail establishment.
New national reporting program via APPRISS HEALTH
Located in RSA318, under Board control? Inspections? Very popular with local police departments……..
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Board approved Rules in Legislative Process:
Cleanup/update rules:
Ph103.04 meetings
Ph103.05 financial disclosure
Ph403.02 CE requirements- add law
Ph 104 Public information requests
Ph 1607 Intern immunization rules update
Ph 2200 investigation rules and forms
Ph 2100 inspection rules and forms
Ph 2400 contraceptive rules/protocol (HB1822)
Ph 900 mail order pharmacies
Ph 2500 drug/device distribution/virtuals (HB615)
Biennial licensing (HB615)
HB627 Veterinarians exception to USP
HB359 warning labels on RX’s containing opioids
HB 463 advanced practice technicians
SB120 move PDMP to stand alone program
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15. Repeals. The following are repealed: 318:45 Sales Permitted. – This chapter shall not prevent the sale of the following:
alum, blue vitriol, borax, camphor gum, copperas, epsom salts, glauber salts, castor
flavoring extracts, and unofficial chlorinated solutions.
Source. 1921, 122:28. PL 210:46. 1931, 123:7. RL 256:46. 318:46 Record Book. – The pharmacist in charge of a pharmacy shall at all times
keep in the pharmacy a record book in which shall be entered all sales of the following, other than sales to physicians, dentists and veterinarians, and sales made upon a prescription of a physician, dentist, veterinarian, or advanced practice registered nurse: arsenous acid (arsenic trioxide), mercuric chloride, hydrocyanic acid, potassium cyanide, cyanide mixture, strychnine and its salts except in proper dosage in pill or tablet form.
Source. 1921, 122:29. PL 210:47. RL 256:47. RSA 318:46. 1973, 453:11. 1994, 333:11.
2009, 54:5, eff. July 21, 2009.
318:47 Keeping and Inspection of Record. – The record required by RSA 318:46
318:47-e Procedures for Dispensing Emergency Contraception. –
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Reorganization of existing and updating rules
Ph300 new rules specific to pharmacists Ph400 new rules specific to institutional
practice and compounding
Ph700 (audit revisions) standards of
practice
Ph1900 new rules specific to pharmacies
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Currently no rules regarding the inspection process Board current responsibilities to inspect every place
there are drugs in state…......
Cited in Legislative Audit of 2008 and 2015 as an issue.
Board inspections do not hold permit holders
accountable to rules
A need to develop a risk-based inspection process. Required to include PDMP program in inspection
process
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Inspections shall be for the following registrants licensee’s
as follows:
Retail pharmacies- annually or based on risk assessment
low, medium, high risk
Institution pharmacies (hospitals, stand-alone emergency
departments and long term care facilities) –annually
Compounding pharmacies –annually Public Health and Methadone Clinics- annually Practitioner/Clinic inspections – every 5 years Veterinarians/veterinary clinics- every 3 years Manufacturer/Wholesaler- every 3 years Limited Retail Drug Distributor- every 3 years
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The following facilities possessing control substances shall
be inspected every two years:
Practitioner/Clinics Veterinarians/veterinary clinics
Inspections with past issues or disciplinary actions will be
conducted annually until compliance deems issues resolved or at request of Administrator/Chief of Compliance.
Compliance staff will review pharmacies annually to
assess risk and make recommendations to the board.
Currently 93 pharmacies identified as “low risk”. All
will receive inspection this year, self inspection 2021.
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Another audit issue that stated we needed to have the
investigation process in rules
QRE report – pharmacists OWN words of issue, NOT
corporates!!
Will be in rule and will be enforced Corporate will have opportunity to file separate
QRE report
Investigations involve professional misconduct
and standards of practice issues.
Are reviewed by the Board and can result in actions
against your license.
Result can be dismissal, letter of concern,
disciplinary actions
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A violation notice shall be given as a notification of non-
compliance with Federal, State, or local laws.
Minor violations will be administrative in nature.
Example: Nametags, paperwork issues etc.
Minor violations shall be issued as a needs
improvement, verbal warning, or violation with fine.
Repeat minor violations will result in Board review
with consideration for further disciplinary action.
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Major violations will be administrative in nature.
Example administrative- refrigerator temperature logs
The Pharmacist-in-charge and/or the pharmacist on duty at
time of violation is responsible for completing violation notice within 15 days of issue.
ALL Violation notices shall be returned to the Board
investigator/inspector in writing with corrected action noted.
Subsequent or multiple violations may result in further
action by the board
Investigators/inspectors shall follow up written violation
notices no later than 60 days after action noted.
Major violations, after board review, shall be maintained in
pharmacist and permit holders permanent file.
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Violation notices for practitioners shall be forwarded to
respective Boards
Violation notices of RSA 318(b) under pharmacy
statutes may result in a fine by Board of Pharmacy
Follow up for violation notices shall be responsibility
Regulatory boards may make a request of pharmacy
board investigators/inspectors for follow up on board actions.
Actions that result in professional
misconduct are reported to national databases and affect your license status.
Regardless of violation or
investigation you have the right to a hearing before the Board!
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Approved final review JLCAR 11/16/17 Final Board approval 12/11/17 Rules approved 1/17/18
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There will be no practice site restrictions with updated rules.
318:16-a Standards for Collaborative Pharmacy Practice. –
(a) Hold an unrestricted and current license to practice as a pharmacist in New Hampshire. (b) Have at least $1,000,000 of professional liability insurance coverage. (e) In order to administer drugs by injection, have completed training that includes programs approved by the Accreditation Council for Pharmacy Education (ACPE) or curriculum-based programs from an ACPE-accredited college of pharmacy or state or local health department programs or programs recognized by the board.
The agreement is between the provider and the
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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
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February 25- May 2, 2019 728 Responses (28% response rate): including 24
retired or non-practicing pharmacists. Results presented include only responses from currently licensed NH pharmacists (non-retired).
Overview: 34 question, anonymous, online survey developed
in partnership between:
February 25- May 2, 2019 Purpose:
Education Support (DSMES), and Collaborative Practice Agreement (CPA) for practicing pharmacists
licensed and practicing in NH.
are needed.
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
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’ Tit itles (n (n=699) Cur Current Practice Settin ing (n (n=717) 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
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: 61% report they “Often” or “Always” provide MTM in the form of edu
education and and tra raining (v (verbal, , onlin
, or
ritten) des desig igned to
nhance pat patient und understandin ing and and appr appropriate use use of
his/h /her medications. s. Other MTM activities were reported to be rarely if ever implemented by pharmacists.
including immunizations)
therapy management services within the broader health care management services being provided to the patient
modification for high blood pressure and high blood cholesterol
written) including referrals to support services and resources designed to enhance patient adherence with his/her therapeutic regimens
response to therapy, including safety and effectiveness
assessments of the patient’s health status
review to identify, resolve, and prevent medication-related problems, including adverse drug events
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% 61% Lack in staffing capacity (n=350) 54% 54% Difficulty in integrating MTM in to current workflow (n=312) 50% 50% Lack in flexibility with time spent dispensing medications versus
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
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.
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.
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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.
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The Board will be looking for:
Policy and procedures Meeting attendance Summary
Starting September 2019, first meeting January 2020
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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
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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
pertaining to the practice of pharmacy in this state and always in the best interest of public health and safety.
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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.
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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!!!!
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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.
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(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)
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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!!
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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%
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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 1st, 2019
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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.
How many of you take a 30 minute uninterrupted
break?
What are the barriers? How to we fix?
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(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.
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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
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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
controlled substances;
(c) Performing stocking or replenishment of automated dispensing
machine, other automated dispensing equipment or other stock
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.
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.
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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.
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
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.
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(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.
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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!!
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(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.
So…….what do you think a marriage of “central fill processing/workflow balancing” and advanced practice technicians is going to do?
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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!!
Board notice of August 16th, 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………….
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SB179-relative to pharmacy administration
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
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How many have issues with
Business issue vs. practice????
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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;
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
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HB 591-FN and HB1746-FN
2018-Prohibited PBM’s from requiring accreditation of
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!!!
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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!!
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Time for a discussion…….
……….Where do we draw the line????
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§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
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.
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. 74 “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
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
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.
improve public safety and public health in New Hampshire.”
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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
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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.
Subutex-suboxone difference
?????reasons why so much being dispense??????
Cost? Allergies????? Remember………corresponding responsibility!!!!
Buprenorphine investigations
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Due Diligence DOCUMENT!!!!! What is in the best interest of the patient?
Scope of practice Questioning/refusing of prescriptions Buprenorphine SL tablets
pain vs MAT Quantity dose
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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 13th, 2018 concerning RSA
318:52 (c) ; sale of hyper dermic syringes and needles
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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:
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.
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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
Seeing issues with multiple visits to providers using
different animal names.
Buprenorphine and tramadol issues. Due diligence!!! Verify RX’s!!!!
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CBD oil an issue………. Agriculture has control…..out of pharmacies
hands…..at the moment……..
Much more to come on this topic….
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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.
Legislative Issues Affecting Pharmacy from 2019 session
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- discussion on PBM’s
HB1822-FN making hormonal contraceptives available
directly from pharmacists by means of a standing
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.
Legislation- contraceptives??
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
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.
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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
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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.
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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?
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329:1-d Telemedicine. –
diagnosis, consultation, or treatment. "Telemedicine" shall not include the use of audio-only telephone or facsimile.
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.
classified in schedule II through IV.
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.
Telemedicine issue
Control drug prescription requirements for ALL prescriptions!!!
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.
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NH PDMP is a clinical tool that exists to promote the appropriate use of controlled medications for legitimate medical purposes, while deterring the misuse and diversion of controlled medications. NH PDMP also serves as a surveillance tool that is used to monitor statewide trends in the prescribing, dispensing, and use of controlled medications. DATA LIMITATION: Opioid addiction treatment programs (OTPs) that dispense methadone and buprenorphine do not upload into the NH PDMP - (CFR 42 part 2 – confidentiality).
Dispensers Prescribers
Medical Examiner Law Enforcement w/Court Order Professional Licensing Agencies Patients Pharmacists
State PDMP
NH NH PD PDMP MP LA LAWS WS
2019 Legislative Changes
HB 369 SB 120
Requires prescribers who write an opioid when treating a patient for an substance use disorder to query the PDMP. This is similar to the mandate that requires a prescriber to query the PDMP when prescribing an opioid to a patient for the treatment and management of pain from HB 1426. Moves the PDMP out from under the authority of the Board of Pharmacy to under the authority of the Office of Professional Licensure and Certification. It also re-designs the focus of the Advisory Council and allows the impaired practitioner program to review PDMP information when retained by OPLC or referral who has agreed to be evaluated has separately agreed in writing.
Practitioner Registration and Patient Query Activity Report (2017 – 2018)
User Role 2018 Registered Users % change from 2017 Physician (MD, PA, DO, Res) 5,784 18% Delegates ** 3,551 56% Pharmacists 3,145 15% Nurse Practitioner / Clinical Nurse Specialist 2,181 20% Dentist 1,090 12% Optometrist/Podiatrist (DPM)/Naturopathic Physisic 365 21% Veterinarian 341 20% Totals 16,457 24%
User Role 2018 Patient Info Requests % change from 2017 Physician (MD, PA, DO, Res) 115,056 91% Delegates 408,857 171% Pharmacists 232,095 173% Nurse Practitioner / Clinical Nurse Specialist 66,547 137% Dentist 23,343 149% Optometrist/Podiatrist (DPM)/Naturopathic Physis 1,677 158% Veterinarian 146
Totals 847,721 153%
Registration Query Requests
Registration is required. The PDMP will be conducting an audit of the of the registrations to identify those licensees who are required to be registered and are not. PDMP queries increased by over 153% between 2017 and 2018. Queries by delegates (171%) and pharmacists (173%) increased dramatically between 2017 and 2018
Pharmacy Chain (grouping) Sum of Total RX Filled Sum of Search Count Ratio RX dispensed to Searches conducted Clinics (Martin's Point, Harbor Homes, etc.) 6,546 1,495 4 Costco 1,786 1,032 2 CVS 245,565 8,406 29
32,648 63 518 Genoa 7,990 42 190 Hannaford 72,983 8,830 8 Hospitals 28,269 10,816 3 Independents 57,912 3,947 15 Rite Aid 278,669 20,097 14 Sam's Club 2,183 3,239 <1 Shaws/Osco 26,097 1,222 21 Walgreens 168,835 9,059 19 Walmart 80,472 42,324 2 Grand Total 1,011,839 111,768 9
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User Role Active users Jul 1, 2017 thru Dec 31, 2017 * Active users Jan 1, 2018 thru Jun 30, 2018 * % Change Physician (MD, PA, DO, Res) 1,920 1,978 3.0% Delegates 1,405 1,697 20.8% Pharmacists 768 830 8.1% Nurse Practitioner / Clinical Nurse Specialist 617 680 10.2% Dentist 201 272 35.3% Optometrist/Podiatrist (DPM)/Naturopathic Physisican 27 29 7.4% Veterinarian 10 6
Totals 4,948 5,492 11.0% 5,000 10,000 15,000 20,000 25,000 30,000 35,000 40,000
Prescribers Pharmacists Delegates
Figure 5
Although prescribers (MD,PA,DO,Res) represent the highest number of registered users, Delegates account for almost twice as many patient inquiries. This was probably caused by clinicians delegating PDMP use to other staff in their practices. Another trend in SFY 2018 utilization data was an increase in active system users. In short, the PDMP is being used more. Overall, the number of active PDMP users increased by 11% during from the previous two quarters of 2017 to the end of 2018. The largest distribution of the increase was for delegates, followed by pharmacists and then prescribers as a combined group.
PDMP UTLIZATION- Patient Inquiries by Active Users
Prescription Drug Use in New Hampshire
Background: How PDMP tracks prescriptions
The information in the PDMP comes from pharmacies. By law, all pharmacies in New Hampshire, including veterinarians, are required to report the controlled substances they dispense to the PDMP. Controlled substances are drugs that can be misused, diverted and may lead to a substance use disorder. Hospitals that administer drugs to patients in their facility are exempt, and do not have to report to the PDMP, as well as wholesale pharmacies. An additional exemption is when a patient is dispensed less than a 48 hour supply of a controlled medication in an ER. This chart shows that for each of SFY 2017 and SFY 2018, prescription counts declined, overall by 7.6%. We attribute this to the timely information prescribers can get from the PDMP, using it as another tool for prescribing decisions.
SFY Q1 SFY Q2 SFY Q3 SFY Q4 SFY 2017 536,571 534,881 516,825 514,739 SFY 2018 506,942 504,728 495,014 495,904
SFY 2017 SFY 2018
470,000 480,000 490,000 500,000 510,000 520,000 530,000 540,000
Count of RX
Prescription Count by SFY Quarter
SFY 2017 – SFY 2018
Figure 7
Prescription Drug Use in New Hampshire
Comparison of Prescription Counts of Opioids to Non-Opioids
Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Opioid 201,247 193,557 178,739 174,311 169,926 165,134 156,889 153,961 100,000 120,000 140,000 160,000 180,000 200,000 220,000Opioids
Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Non-Opioid 285,954 288,239 284,636 288,385 285,228 285,810 282,507 287,480250,000 255,000 260,000 265,000 270,000 275,000 280,000 285,000 290,000 295,000 300,000
Non-Opioids
Non-Opioid RX quarterly counts show a variation
trend line over two years is essentially flat with minimal change in RX count. Opioid RX quarterly counts show a steep decline
total RX (shown previously) is driven almost entirely by a decrease in opioid RX.
Figure 8 Figure 9
Prescription Drug Use in New Hampshire
Average Number of Units and Average Days Supply per Prescription – Opioids only
Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Ave Nbr Units 61.6 62.2 63.8 64.9 64.6 64.3 63.8 64.2 Ave Days Supply 16.4 16.6 17.1 17.5 17.6 17.5 17.5 17.7 Ave Nbr Units, 61.6 Ave Nbr Units, 64.2Ave Days Supply, 16.4
Ave Days Supply, 17.7 15.5 16.0 16.5 17.0 17.5 18.0 60.0 61.0 62.0 63.0 64.0 65.0 66.0 Ave Days SupplyAve Nbr units
Ave Days Supply, 16.4 Figure 12 Ave Days Supply, 17.7
Prescription Drug Use in New Hampshire
The percentage of all controlled substance prescriptions by age range compared to the percentage of opioid only prescriptions. SFY 2017 and 2018 combined.
New Hampshire’s 55 and older population are prescribed over half (54.7%) of all opioid
for makes up a third of all opioid prescriptions. In essence, as the age of patients increase, the prescribing of Controlled Substances increases.
Under 18 18-34 35-44 45-54 55-64 65 and older % of All CS RX 6.2% 16.4% 13.5% 17.1% 21.8% 25.1%Under 18 18-34 35-44 45-54 55-64 65 and older 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0%
% of All CS RX
Under 18 18-34 35-44 45-54 55-64 65 and
% of Opioid RX 1.5% 13.3% 13.1% 17.4% 24.3% 30.4%
Under 18 18-34 35-44 45-54 55-64 65 and older 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0%
% of Opioid RX
Figure 10 Figure 11
Number of Opioid RX per 1,000 residents, where the RX indicated both the prescriber and the pharmacy had an NH address. The data show that half of NH Counties are above the statewide value and half are below. 598 521 456 454 447 435 410 389 371 339 289
100 200 300 400 500 600 700 Merrimack Strafford Coos Carroll Rockingham All of NH Belknap Hillsborough Cheshire Grafton Sullivan
Prescription Drug Use in New Hampshire
By County – Opioids Only SFY 2018 only
Population Estimate from US Census, July 2017
Figure 13
Prescription Drug Use in New Hampshire
Percent of Rx Greater than 100 MME
Opioid Rx only; SFY 2017 – SFY 2018 (Excludes Buprenorphine & Naloxone). Morphine Milligram Equivalent (MME) is the amount of morphine equivalent to the strength of the
19.0% 18.1% 18.3% 17.7% 15.9% 15.8% 17.6% 17.2% 10% 11% 12% 13% 14% 15% 16% 17% 18% 19% 20%
All Prescribers
Prescription Drug Use in New Hampshire
Percent of patients prescribed long-acting/extended release opioids who were
Measured using all controlled substance prescriptions. Opioid-naïve is defined as a patient who had not received an opioid prescription in the prior 90 days.
9.9% 10.5% 11.7% 10.5% 8.7% 16.8% 12.0% 15.5% 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20%
All Prescribers
Prescription Drug Use in New Hampshire
Percent of prescribed opioid days that overlap with benzodiazepine prescriptions. Patients with combined prescription use of both drugs may be more at risk to become addicted or to die from an overdose. (Source: CDC)
19.0% 18.5% 18.2% 18.5% 19.8% 18.6% 17.4% 16.6% 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20% 22% 24%
All Prescribers
Grant
PDMP data is being uploaded & uploaded accurately in accordance to the law and rules – CDC Grant.
effective September 27th, 2019!!!
PDMP Data Audit & Compliance Project
To assist with improving data and making better
linkages – the PDMP will receive CDC funds to hire temporary staff to implement a PDMP Audit:
Determine New Hampshire’s PMP data accuracy
by:
Implementing a standardized process for evaluating its
accuracy
Taking the necessary steps to correct the data if errors
are identified
Prevent incidences of errors
Started June 1st, 2019
Audit Process
PDMP Auditor sends audit Notice to PIC with 8 pre-chosen prescription numbers asking to prepare
documents
PIC prepares the filling tag, back tag, copy of the prescription, and make original prescription readily retrievable BOP Compliance Inspectors visit pharmacy and look at documents, comparing back tag/filling tag with
marking on form.
additional prescriptions randomly for the audit
BOP Compliance Inspectors bring form and prescriptions back to PDMP office
PDMP auditor compares information to PDMP
reported to administrator
be further reported to the BOP for further review
Pharmacies that pass audit are provided notice and nothing further needs to be done. Pharmacies that fail the audit: PDMP auditor informs these pharmacies
hours to correct errors
hours = good job
hours = reported to BOP
(P (Prescriber Full ll Name, Address & DEA)
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Pharmacists questions By current rule, how often should a pharmacist check the Prescription Drug
Monitoring Program?
a. Every time they fill a prescription for Tramadol b. Make a reasonable attempt to verify all control drug medications c. When time permits d. Not required to check at any time Dental Hygienists have prescriptive authority from the dental board to
prescribe which of the following:
a. oral and topical antibiotics b. triamcinolone in orabase c. Chlorhexedine gluconate oral rinse d. None, pharmacy statutes do not address Dental Hygienists prescriptive
authority.
What current information is required by the Board for a pharmacist to
participate in a collaborative practice?
a. a signed agreement on pharmacists duties with a single provider. b. 20 additional hours of continuing education in specialty annually. c. pass a Board approved exam on specialty of practice. d. no requirements necessary.
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Technicians questions
their registration?