Section 3.0 Definitions
3.1 "Administered" means direct application
of a drug to the body of a patient by means of injection, inhalation, ingestion
or any other means.
3.2 "Chronic
Pain" means pain caused by various diseases or abnormal conditions and that
continues longer than 90 days.
3.3
"Commissioner" means the Commissioner of Health.
3.4 "Controlled substance" means a substance
listed on the Federal Drug Enforcement Administration's Schedules II, III or IV
as defined in 21 C.F.R. Part
1308.
3.5 "DEA" means the Federal Drug Enforcement
Administration.
3.6 "Delegates" are
individuals employed by prescribers, pharmacists, or the Vermont Chief Medical
Examiner who are authorized by these entities to access the VPMS database
related to the clinical care of bona fide current patients of the authorizing
health care prescriber or dispenser or related to a bona fide investigation or
inquiry into an individual's death by the Chief Medical Examiner.
3.7 "Department" means the Vermont Department
of Health.
3.8 "Dispensed" means a
Schedule II, III, or IV controlled substance given to a patient by a pharmacy
or prescriber pursuant to an order by a prescriber.
3.9 "Dispenser" means a pharmacy or
prescriber that prepares and delivers a Schedule II, III, or IV controlled
substance for a patient pursuant to an order by a prescriber.
3.10 "Drug Diversion Investigator" means an
employee of the Department of Public Safety whose primary duties include
investigations involving violations of laws regarding prescription drugs or the
diversion of prescribed controlled substances, and who has completed a training
program offered or designated by the Department of Health designed to ensure
that officers have the training necessary to use responsibly and properly any
information that he or she receives from the VPMS.
3.11 "OBOT" means Office Based Opioid
Treatment physician practice for prescribing buprenorphine as established by
the Drug Abuse and Treatment Act of 2000. In Vermont, OBOTs are often referred
to as "Spokes". An OBOT may be a preferred provider, an individual physician
practice or several physicians practicing as a group.
3.12 "OTP" means an Opioid Treatment Program
as defined and regulated by federal regulation 42 R, Part 8 and DEA regulations
related to safe storage and dispensing at OTPs ( § 1301.72). OTPs are
specialty addiction treatment programs for dispensing opioid-replacement
medication including methadone and buprenorphine under carefully controlled and
observed conditions. OTPs offer onsite ancillary services. In Vermont, OTPs are
sometimes referred to as "Hubs".
3.13 "Palliative care" as defined in
18 V.S.A. section
2(6) means interdisciplinary
care given to improve the quality of life of patients and their families facing
the problems associated with a serious medical condition,
3.14 "Pharmacist" means a health care
professional licensed to dispense Schedule II, III or IV controlled substances
as defined by the Vermont Administrative Rules of the Board of Pharmacy.
3.15
3.15 "Pharmacy" means an
entity that dispenses Controlled Substances, or provides pharmaceutical care,
as defined by the Vermont Administrative Rules of the Board of
Pharmacy.
3.16 "Prescriber" means a
health care professional licensed to prescribe Schedule II, III or IV
controlled substances.3.17
3.17
"Query" means the action of accessing a Prescription Drug Monitoring Program
and retrieving information from it regarding controlled substance(s) prescribed
or dispensed to a patient.
3.18
"Reciprocal Agreements" means a written agreement that provides for the
exchange of information requests and responses of Prescription Drug Monitoring
Program data between state data-sharing partners if access under such agreement
is consistent with the privacy, security, and disclosure protections under the
statute and these regulations.
3.19
"Replacement prescription" means an unscheduled prescription request in the
event that the document on which a patient's prescription was written has been
lost or stolen, or the patient's prescribed medication is reported to the
prescriber as having been lost or stolen.
3.20 "Report of Controlled Substances
Dispensed" means the report format used by pharmacies for submitting required
data to the VPMS pursuant to this rule.
3.21 "Reportable prescription" means each
controlled substance dispensed from any Vermont-licensed pharmacy.
3.22 Unsolicited Report" is a notification
sent to a patient's provider when clinical thresholds established by the
Department have been met or exceeded.
3.23 "Vermont Prescription Monitoring System"
(VPMS) means the statewide database that collects data on Schedule II, III, or
IV controlled substances dispensed by a Vermont-licensed pharmacy.
Section 4.0 Required Reporting for
Pharmacies and Prescribers who Dispense Controlled Substances
4.1 Filing of Report of Controlled Substances
Dispensed
4.1.1 Pharmacies and other
dispensers shall report each dispensed prescription for a Schedule II, III, or
IV controlled substance to the VPMS within either 24 hours or one business day
of dispensing the prescription. This applies to all licensees, irrespective of
location or number of prescriptions of controlled substances
dispensed.
4.1.2 Pharmacies and
other dispensers must submit a "zero controlled substances report" on any day
that no controlled substances are dispensed.
4.2 Required Information from Reporting
Pharmacy
4.2.1 The Report of Controlled
Substances Dispensed from each pharmacy shall include the data elements
detailed in the VPMS Data Collection Manual. These data elements include
information related to the patient, prescription, dispenser, and
prescriber.4.2.2 Those who are responsible for submitting data for multiple
pharmacies or locations may submit a single report for all of its their
pharmacies. The report shall identify the specific pharmacy or location from
which each reportable prescription was dispensed.
4.3 Distribution of Advisory Notices
4.3.1 Each pharmacy shall provide to every
customer to whom a controlled substance is dispensed an advisory notice
informing the customer that all prescriptions for controlled substances are
entered into a statewide VPMS database in order to protect patients and the
public. The advisory notices are available on the Department's website.
4.3.1.1 Pharmacies shall provide these
notices by:
-- Prominently displaying the advisory notice in a manner
readily accessible to its customers; or
-- Duplicating the complete text of the advisory notice in
another format, such as by printing it on customer receipts, patient
instructions; or on a written insert for delivery to the
patient.
4.3.2
The pharmacy shall post brief advisories in at least six (6) languages offering
a referral telephone number for people with limited English
proficiency.
4.4
Required Data Submission for Prescribers that Dispense
Prescribers who dispense controlled substances to their
patients must submit a Report of Controlled Substances Dispensed to the VPMS
following the same frequency and format as described in Sections 4.1 and 4.2 of
this rule.
4.5 Exemptions
from Reporting to VPMS
4.5.1 Reporting to VPMS
is not required for:
-- Pharmacies that do not sell or dispense any Schedule II-IV
controlled substances;
-- Out-of-State pharmacies that do not sell or dispense any
Schedule II-IV controlled substances to any resident in Vermont;
-- A drug administered directly to a patient;
-- A drug dispensed by a health care provider (at a facility
licensed by the Department), provided that the quantity dispensed is limited to
an amount adequate to treat the patient for a maximum of 48 hours;
-- Veterinary Offices; or
-- Opioid Treatment Programs that dispense only methadone and
buprenorphine.
4.5.2 A
pharmacy that meets at least one of the above criteria may request an exemption
from reporting from the VPMS program. The exemption shall terminate when the
pharmacy dispenses any controlled substance or no longer meets the criteria for
exemption.
4.5.3 The pharmacy shall
renew the exemption form on an annual basis.
Section 5.0 Requirements for Pharmacists
5.1 Pharmacist Registration with the VPMS
5.1.1 All Vermont-licensed pharmacists shall
register to query the VPMS.
5.2 Pharmacist Required Querying of the VPMS
All dispensers, with the exception of hospital-based
dispensers dispensing a quantity of a Schedule II, III, or IV opioid controlled
substance that is sufficient to treat a patient for fewer than 48 hours, shall
query the Vermont Prescription Monitoring System in the following
circumstances:
5.2.1 Prior to
dispensing a prescription for a Schedule II, III, or IV opioid controlled
substance to a patient who is new to the pharmacy when such a prescription
exceeds ten pills or the equivalent;
5.2.2 When an individual pays cash for a
prescription for a Schedule II, III, or IV opioid controlled substance and the
individual has prescription drug coverage on file;
5.2.3 When a patient requests a refill of a
prescription for a Schedule II, III, or IV opioid controlled substance
substantially in advance of when a refill would ordinarily be due;
and
5.2.4 When the dispenser is
aware that the patient is being prescribed Schedule II, III, or IV opioid
controlled substances by more than one prescriber.
5.3 Pharmacist Delegates
Pharmacists may designate a delegate or delegates to access
and query the VPMS system subject to Section 7.2 of this rule.
Section 6.0 Requirements for
Prescribers
6.1 Prescriber Registration with
the VPMS
The following professionals and entities must register with
the Department to enable their access to the VPMS system:
6.1.1 All Vermont-licensed prescribers of
controlled substances and their delegates;
6.1.2 The Medical Director of the Department
of Vermont Health Access; and
6.1.3
Vermont's Medical Examiners, and delegates from the Chief Medical Examiner's
Office investigating deaths in Vermont.
6.2 Prescriber-Required Querying of VPMS
Prior to prescribing a controlled substance for a patient,
Vermont licensed prescribers and/or their delegates must query the VPMS system
in the following circumstances:
6.2.1
The first time the provider prescribes an opioid Schedule II, III, or IV
controlled substance written to treat pain;
6.2.2 When starting a patient on a Schedule
II, III, or IV controlled substance for nonpalliative long-term pain therapy of
90 days or more;
6.2.3 Prior to
writing a replacement prescription for a Schedule II, III, or IV controlled
substance;
6.2.4 At least annually
for patients who are receiving ongoing treatment (treatment without meaningful
interruption) with an opioid Schedule II, III, or IV controlled
substance;
6.2.5 The first time a
provider prescribes a benzodiazepine;
6.2.6 When a patient requests an opioid
prescription or a renewal of an existing prescription for pain from an
Emergency Department or Urgent Care prescriber if the prescriber intends to
write a prescription for an opioid;
6.2.7 With the exception of prescriptions
written from an OTP, prior to prescribing buprenorphine or a drug containing
buprenorphine to a Vermont patient for the first time and at regular intervals
thereafter, and:
6.2.7.1 At regular intervals
thereafter, but no less than twice annually; and
6.2.7.2 No fewer than two times annually
thereafter; and
6.2.7.3 Prior to
writing a replacement prescription.
6.2.8 In the case of an OTP, prior to
prescribing buprenorphine, methadone, or a drug containing buprenorphine to a
Vermont patient for the first time, and:
6.2.8.1 Annually thereafter; and
6.2.8.2 Any other time that is clinically
warranted.
6.2.9 Prior
to prescribing buprenorphine or a drug containing buprenorphine that exceeds
the dosage threshold approved by the Vermont Medicaid Drug Utilization Review
Board and published in its Preferred Drug List [1], prescribers must receive
prior approval from the Chief Medical Officer or Medical Director of the
Department of Vermont Health Access or designee.
6.3 Prescriber Delegates
Prescribers may designate a delegate or delegates to access
and query the VPMS system subject to Section 7.2 of this rule.
6.4 Exemptions
Patients experiencing chronic pain in the following
categories are exempt from the requirements found in this section:
-- Chronic pain associated with cancer or cancer
treatment;
-- Palliative care;
-- End-of-life and hospice care; and
-- Patients in skilled and intermediate care nursing
facilities.
Section
7.0 Access to VPMS Information
7.1 Authority to Query VPMS Directly
Once registered, the following persons and entities may query
VPMS directly for the following information:
7.1.1 Pharmacists who dispense controlled
substances and their authorized delegates for the purpose of monitoring the
prescription and dispensing history of a bona fide current patient;
7.1.2 Prescribers of controlled substances
and their authorized delegates for the purpose of monitoring the prescription
and dispensing history of a bona fide current patient;
7.1.3 The Vermont Chief Medical Examiner or
delegate as required for the purpose of conducting an investigation or inquiry
into the cause, manner and circumstances of an individual's death;
7.1.4 The Medical Director of the Department
of Vermont Health Access relating to a Medicaid recipient for whom a claim for
a Schedule II, III, or IV was submitted. This access is for Medicaid quality
assurance, utilization, and federal monitoring purposes; and
7.1.5 The VPMS program manager, designated
program staff, or any contractors acting at the direction of, or as authorized
by, the program manager for purposes of management of the VPMS
database.
7.2 VPMS
Querying by Delegates
7.2.1 Delegates must
register with the VPMS under a registered pharmacist, prescriber, or the
Vermont Chief Medical Examiner in order to access and query the VPMS system.
7.2.1.1 Delegates may register as a delegate
under multiple prescribers.
7.2.1.2
Delegates must accurately assign each query to the appropriate
prescriber.
7.2.2 The
authorizing registrant must approve the delegate before the delegate is issued
access, and is responsible for the delegate's appropriate use of the
VPMS.
7.2.3 Any and all information
requested by the delegate is for the purpose of providing treatment to a bona
fide current patient of the authorizing pharmacist or prescriber, or in the
case of the Office of the Chief Medical Examiner for the purpose of conducting
an inquiry or investigation into an individual's death.
7.2.4 The delegate shall notify the
prescriber of findings of the delegate's query, prior to the prescriber writing
a new prescription for controlled substances.
7.3 Requests for VPMS Information by Those
without Direct Access for Querying the System
The following persons and entities may request from the VPMS
program manager information for the following purposes:
7.3.1 Individual Records
7.3.1.1 A patient may request information
from VPMS relating to themselves.
7.3.1.2 The request shall be submitted to the
Department in writing using the Patient Prescription History Request Form, and
shall be signed by the patient and shall include:
-- The patient's name;
-- The patient's date of birth;
-- The time period for which the information is
requested;
-- The patient's telephone number, mailing address;
-- The patient's original signature; and
-- A copy of a federally recognized form of photo
identification (such as a driver's license or passport) or a Vermont Driver's
Privilege Card.
A copy of the Patient Prescription History Request Form can
be found on the Health Department's website.
7.3.1.3 In order to submit the Patient
Prescription History Request Form, the individual may:
-- Mail a notarized original to the Health Department.
-- Present the form to the Health Department
in-person.
7.3.2
Professional Boards
7.3.2.1 A designated
representative of a professional board that is responsible for the licensure,
regulation or discipline of health care prescribers or dispensers may request
information from the VPMS pursuant to a bona fide specific investigation. The
request shall be submitted on a form provided by the Department on the VPMS
website and shall include:
-- The name of the licensee, if applicable;
-- The licensee's DEA number, if applicable;
-- The timeframe under investigation;
-- The requester's name;
-- The requester's telephone number, mail and street
address;
-- A statement certifying that the request is pursuant to a
bona fide specific investigation; and
-- A statement certifying that the requester is duly
designated by the board of licensure to make the request.
7.3.2.2 The request shall be delivered by
secure fax, password-protected e-mail, or in person to VPMS staff.
Section 9.0 Enforcement
9.1 Prescribers are bound by the requirements
of this rule and are subject to sanctions by their licensing authority for
failure to comply with it.
9.2 A
dispenser who intentionally fails to comply with the reporting requirements
specified in this rule shall be subject to discipline by the board of pharmacy,
or other appropriate licensing authority, as provided in
18 V.S.A. §
4283(h).
9.3 The Department may refer to the
appropriate licensing authority any pharmacy that fails to submit a timely or
complete Report of Controlled Substances Dispensed.
9.4 If the VPMS shows that a patient has
filled a prescription for a controlled substance written by a prescriber who is
not a registered user of VPMS, the Commissioner of Health will notify the
professional by email or United States Postal Service and will notify the
applicable licensing authority.
