WEST virginia legislature
2017 regular session
Committee Substitute
for
Senate Bill 333
By Senators Takubo, Palumbo, Stollings, Romano, Cline and Maroney
[Originating in the Committee on Health and Human Resources; reported on March 8, 2017]
A BILL to amend and reenact §60-A-9-4 of the Code of West Virginia, 1931, as amended; to amend and reenact §60A-9-5 and §60A-9-5a of said code; and to amend said code by adding thereto a new section, designated §60A-9-9, all relating the Controlled Substances Monitoring Program database; requiring reporting instances of an overdose or a suspected overdose to the database; setting out elements to be reported; allowing access to the database to deans of the state’s medical schools to monitoring prescribing practices of residents; allowing the Board of Pharmacy to require that drugs of concern be reported to the database; exempting reporting requirements for drugs of concern from criminal penalties; allowing the Board of Pharmacy to develop administrative penalties for not reporting drugs of concern; providing for rulemaking; requiring the licensing boards to report to the Board of Pharmacy when notified of unusual prescribing habits of a licensee; and making technical corrections.
Be it enacted by the Legislature of West Virginia:
That §60A-9-4 of the Code of West Virginia, 1931, as amended, be amended and reenacted; that §60A-9-5 and §60A-9-5a of said code be amended and reenacted; that said code by amended by adding thereto a new section, designated §60A-9-9, all to read as follows:
ARTICLE 9. CONTROLLED SUBSTANCES MONITORING.
§60A-9-4. Required information.
(a) Whenever a
medical services provider dispenses a controlled substance listed in Schedule
II, III or IV as established under the provisions of article two of this
chapter or an opioid antagonist, or whenever a prescription for the controlled
substance or opioid antagonist is filled by: (i) A pharmacist or pharmacy in
this state; (ii) a hospital, or other health care facility, for out-patient
use; or (iii) a pharmacy or pharmacist licensed by the Board of Pharmacy, but
situated outside this state for delivery to a person residing in this state,
the medical services provider, health care facility, pharmacist or pharmacy
shall, in a manner prescribed by rules promulgated by the board under Board
of Pharmacy pursuant to this article, report the following information, as
applicable:
(1) The name, address, pharmacy prescription number and Drug Enforcement Administration controlled substance registration number of the dispensing pharmacy or the dispensing physician or dentist;
(2) The full legal name, address and birth date of the person for whom the prescription is written;
(3) The name, address and Drug Enforcement Administration controlled substances registration number of the practitioner writing the prescription;
(4) The name and national drug code number of the Schedule II, III and IV controlled substance or opioid antagonist dispensed;
(5) The quantity and dosage of the Schedule II, III and IV controlled substance or opioid antagonist dispensed;
(6) The date the prescription was written and the date filled;
(7) The number of refills, if any, authorized by the prescription;
(8) If the
prescription being dispensed is being picked up by someone other than the
patient on behalf of the patient, the first name, last name and middle initial,
address and birth date of the person picking up the prescription as set forth
on the person's government-issued photo identification card shall be retained
in either print or electronic form until such time as otherwise directed by
rule promulgated by the board Board of Pharmacy; and
(9) The source of payment for the controlled substance dispensed.
(b) Whenever a medical services provider treats a patient and an overdose has occurred or is suspected as a result of illicit or prescribed medication the medical service provider shall report the full legal name, address and birth date of the person for whom treatments for an overdose or suspected overdose is provided including any known ancillary evidence of the overdose or suspected overdose including, but not limited to, the source of the overdose or potential overdose, if known, any family history of substance use, positive drugs screens and any other evidence of the overdose or suspected overdose.
(b) (c)
The board Board of Pharmacy may prescribe by rule promulgated under
this pursuant to this article the form to be used in prescribing a
Schedule II, III, and IV substance or opioid antagonist if, in the
determination of the board Board of Pharmacy, the administration
of the requirements of this section would be facilitated.
(c) (d)
Products regulated by the provisions of article ten of this chapter shall be
subject to reporting pursuant to the provisions of this article to the extent
set forth in said article.
(d) (e)
Reporting required by this section is not required for a drug administered
directly to a patient by a practitioner. Reporting is, however, required by
this section for a drug dispensed to a patient by a practitioner. Provided,
That the The quantity dispensed by a prescribing practitioner to his
or her own patient may not exceed an amount adequate to treat the patient for a
maximum of seventy-two hours with no greater than two seventy-two-hour cycles
dispensed in any fifteen-day period of time.
(e) (f) The Board of
Pharmacy shall notify a physician prescribing buprenorphine or
buprenorphine/naloxone within sixty days of the availability of the an
abuse deterrent form of buprenorphine or buprenorphine/naloxone is if
approved by the Food and Drug Administration as provided in FDA Guidance to
Industry. Upon receipt of the notice, a physician may switch their patients
using buprenorphine or buprenorphine/naloxone to the abuse deterrent form of
the drug.
§60A-9-5. Confidentiality; limited access to records; period of retention; no civil liability for required reporting.
(a)(1) The
information required by this article to be kept by the board Board of
Pharmacy is confidential and not subject to the provisions of chapter
twenty-nine-b of this code or obtainable as discovery in civil matters absent a
court order and is open to inspection only by inspectors and agents of the board
Board of Pharmacy, members of the West Virginia State Police expressly
authorized by the Superintendent of the West Virginia State Police to have
access to the information, authorized agents of local law-enforcement agencies
as members of a federally affiliated drug task force, authorized agents of the
federal Drug Enforcement Administration, duly authorized agents of the Bureau
for Medical Services, duly authorized agents of the Office of the Chief Medical
Examiner for use in post-mortem examinations, duly authorized agents of
licensing boards of practitioners in this state and other states authorized to
prescribe Schedules II, III and IV controlled substances, prescribing
practitioners and pharmacists, a dean of any medical school located in this
state to monitor prescribing practices of residents enrolled ina medical degree
program at the school where they are dean and persons with an enforceable
court order or regulatory agency administrative subpoena. Provided,
That all All law-enforcement personnel who have access to the
Controlled Substances Monitoring Program database shall be granted access in
accordance with applicable state laws and the board's legislative Board
of Pharmacy’s rules, shall be certified as a West Virginia law-enforcement
officer and shall have successfully completed training approved by the board
Board of Pharmacy. All information released by the board Board
of Pharmacy must be related to a specific patient or a specific individual
or entity under investigation by any of the above parties except that
practitioners who prescribe or dispense controlled substances may request
specific data related to their Drug Enforcement Administration controlled
substance registration number or for the purpose of providing treatment to a
patient: Provided, however, That the West Virginia Controlled
Substances Monitoring Program Database Review Committee established in
subsection (b) of this section is authorized to query the database to comply
with said subsection.
(2) Subject to
the provisions of subdivision (1) of this subsection, the board Board
of Pharmacy shall also review the West Virginia Controlled Substance
Monitoring Program database and issue reports that identify abnormal or unusual
practices of patients who exceed parameters as determined by the advisory
committee established in this section. The board Board of Pharmacy
shall communicate with practitioners and dispensers to more effectively manage
the medications of their patients in the manner recommended by the advisory
committee. All other reports produced by the board Board of Pharmacy
shall be kept confidential. The board Board of Pharmacy shall
maintain the information required by this article for a period of not less than
five years. Notwithstanding any other provisions of this code to the contrary,
data obtained under the provisions of this article may be used for compilation
of educational, scholarly or statistical purposes, and may be shared with the
West Virginia Department of Health and Human Resources for those purposes, as
long as the identities of persons or entities and any personally identifiable
information, including protected health information, contained therein shall be
redacted, scrubbed or otherwise irreversibly destroyed in a manner that will preserve
the confidential nature of the information. No individual or entity required to
report under section four of this article may be subject to a claim for civil
damages or other civil relief for the reporting of information to the board Board
of Pharmacy as required under and in accordance with the provisions of this
article.
(3) The board
Board of Pharmacy shall establish an advisory committee to develop,
implement and recommend parameters to be used in identifying abnormal or
unusual usage patterns of patients in this state. This advisory committee
shall:
(A) Consist of
the following members: A physician licensed by the West Virginia Board of
Medicine, a dentist licensed by the West Virginia Board of Dental Examiners, a
physician licensed by the West Virginia Board of Osteopathic Medicine, a
licensed physician certified by the American Board of Pain Medicine, a licensed
physician board certified in medical oncology recommended by the West Virginia
State Medical Association, a licensed physician board certified in palliative
care recommended by the West Virginia Center on End of Life Care, a pharmacist
licensed by the West Virginia Board of Pharmacy, a licensed physician member of
the West Virginia Academy of Family Physicians, an expert in drug diversion and
such other members as determined by the board Board of Pharmacy.
(B) Recommend parameters to identify abnormal or unusual usage patterns of controlled substances for patients in order to prepare reports as requested in accordance with subsection (a), subdivision (2) of this section.
(C) Make recommendations for training, research and other areas that are determined by the committee to have the potential to reduce inappropriate use of prescription drugs in this state, including, but not limited to, studying issues related to diversion of controlled substances used for the management of opioid addiction.
(D) Monitor the ability of medical services providers, health care facilities, pharmacists and pharmacies to meet the twenty-four hour reporting requirement for the Controlled Substances Monitoring Program set forth in section three of this article, and report on the feasibility of requiring real-time reporting.
(E) Establish outreach programs with local law enforcement to provide education to local law enforcement on the requirements and use of the Controlled Substances Monitoring Program database established in this article.
(b) The board
Board of Pharmacy shall create a West Virginia Controlled Substances
Monitoring Program Database Review Committee of individuals consisting of two
prosecuting attorneys from West Virginia counties, two physicians with
specialties which require extensive use of controlled substances and a
pharmacist who is trained in the use and abuse of controlled substances. The
review committee may determine that an additional physician who is an expert in
the field under investigation be added to the team when the facts of a case
indicate that the additional expertise is required. The review committee,
working independently, may query the database based on parameters established
by the advisory committee. The review committee may make determinations on a
case-by-case basis on specific unusual prescribing or dispensing patterns
indicated by outliers in the system or abnormal or unusual usage patterns of
controlled substances by patients which the review committee has reasonable
cause to believe necessitates further action by law enforcement or the
licensing board having jurisdiction over the practitioners or dispensers under
consideration. The licensing board having jurisdiction over the practitioner
or dispenser under consideration shall report back to the Board of Pharmacy
regarding any findings, investigation or discipline resulting from the findings
of the review committee within thirty days of resolution of any action taken by
the licensing board resulting from the information provided by the Board of
Pharmacy. The review committee shall also review notices provided by the
chief medical examiner pursuant to subsection (h), section ten, article twelve,
chapter sixty-one of this code and determine on a case-by-case basis whether a
practitioner who prescribed or dispensed a controlled substance resulting in or
contributing to the drug overdose may have breached professional or
occupational standards or committed a criminal act when prescribing the
controlled substance at issue to the decedent. Only in those cases in which
there is reasonable cause to believe a breach of professional or occupational
standards or a criminal act may have occurred, the review committee shall
notify the appropriate professional licensing agency having jurisdiction over
the applicable practitioner or dispenser and appropriate law-enforcement
agencies and provide pertinent information from the database for their consideration.
The number of cases identified shall be determined by the review committee
based on a number that can be adequately reviewed by the review committee. The
information obtained and developed may not be shared except as provided in this
article and is not subject to the provisions of chapter twenty-nine-b of this
code or obtainable as discovering in civil matters absent a court order.
(c) The board
Board of Pharmacy is responsible for establishing and providing
administrative support for the advisory committee and the West Virginia
Controlled Substances Monitoring Program Database Review Committee. The
advisory committee and the review committee shall elect a chair by majority
vote. Members of the advisory committee and the review committee may not be
compensated in their capacity as members but shall be reimbursed for reasonable
expenses incurred in the performance of their duties.
(d) The board
Board of Pharmacy shall promulgate rules with advice and consent of the
advisory committee, in accordance with the provisions of article three, chapter
twenty-nine-a of this code. The legislative rules must include, but shall not
be limited to, the following matters:
(1) Identifying parameters used in identifying abnormal or unusual prescribing or dispensing patterns;
(2) Processing parameters and developing reports of abnormal or unusual prescribing or dispensing patterns for patients, practitioners and dispensers;
(3) Establishing the information to be contained in reports and the process by which the reports will be generated and disseminated; and
(4) Setting up processes and procedures to ensure that the privacy, confidentiality, and security of information collected, recorded, transmitted and maintained by the review committee is not disclosed except as provided in this section.
(e) Persons or
entities with access to the West Virginia Controlled Substances Monitoring
Program database pursuant to this section may, pursuant to rules promulgated by
the board Board of Pharmacy, delegate appropriate personnel to
have access to said database.
(f) Good faith reliance by a practitioner on information contained in the West Virginia Controlled Substances Monitoring Program database in prescribing or dispensing or refusing or declining to prescribe or dispense a schedule II, III, or IV controlled substance shall constitute an absolute defense in any civil or criminal action brought due to prescribing or dispensing or refusing or declining to prescribe or dispense.
(g) A prescribing or dispensing practitioner may notify law enforcement of a patient who, in the prescribing or dispensing practitioner's judgment, may be in violation of section four hundred ten, article four of this chapter, based on information obtained and reviewed from the controlled substances monitoring database. A prescribing or dispensing practitioner who makes a notification pursuant to this subsection is immune from any civil, administrative or criminal liability that otherwise might be incurred or imposed because of the notification if the notification is made in good faith.
(h) Nothing in the article may be construed to require a practitioner to access the West Virginia Controlled Substances Monitoring Program database except as provided in section five-a of this article.
(i) The board Board of
Pharmacy shall provide an annual report on the West Virginia Controlled
Substance Monitoring Program to the Legislative Oversight Commission on Health
and Human Resources Accountability with recommendations for needed legislation
no later than January 1 of each year.
§60A-9-5a. Practitioner requirements to access database and conduct annual search of the database; required rulemaking.
(a) All practitioners, as that term is defined in
section one hundred-one, article two of this chapter who prescribe or dispense
Schedule II, III or IV controlled substances shall register with the West
Virginia Controlled Substances Monitoring Program and obtain and maintain
online or other electronic access to the program database: Provided,
That compliance with the provisions of this subsection must be accomplished
within thirty days of the practitioner obtaining a new license: Provided,
however, That no licensing board Board of Pharmacy may renew
a practitioner’s license without proof that the practitioner meet the
requirements of this subsection.
(b) Upon initially prescribing or dispensing any pain-relieving
controlled substance for a patient for whom they are providing pain-relieving
controlled substances as part of a course of treatment for chronic,
nonmalignant pain but who are not suffering from a terminal illness and at
least annually thereafter should the practitioner or dispenser continue to
treat the patient with controlled substances, all persons with prescriptive or
dispensing authority and in possession of a valid Drug Enforcement
Administration registration identification number and, who are licensed by the
Board of Medicine as set forth in article three, chapter thirty of this code,
the Board of Registered Professional Nurses as set forth in article seven,
chapter thirty of this code, the Board of Dental Examiners as set forth in
article four, chapter thirty of this code and the Board of Osteopathic Medicine
as set forth in article fourteen, chapter thirty of this code shall access the
West Virginia Controlled Substances Monitoring Program database for information
regarding specific patients for whom they are providing pain-relieving
controlled substances as part of a course of treatment for chronic,
nonmalignant pain but who are not suffering from a terminal illness. The
information obtained from accessing the West Virginia Controlled Substances
Monitoring Program database for the patient shall be documented in the patient's
medical record maintained by a private prescriber or any inpatient facility
licensed pursuant to the provisions of chapter sixteen of this code. A pain-relieving
controlled substance shall be defined as set forth in section one, article
three-a, chapter thirty of this code.
(c) The various boards mentioned in subsection (b) of this section above shall promulgate both emergency and legislative rules pursuant to the provisions of article three, chapter twenty-nine-a of this code to effectuate the provisions of this section.
§60A-9-9. Drugs of concern designation.
(a) The Board of Pharmacy may designate certain drugs as drugs of concern which must be reported to the database established pursuant to this article. Drugs of concern shall consist of drugs which have a high potential for abuse. Whenever a medical services provider dispenses a drug which is listed as a drug of concern as established pursuant to this section and any rules promulgated pursuant to this section, or whenever a prescription for a drugs listed as a drug of concern is filled by: (i) A pharmacist or pharmacy in this state; (ii) a hospital, or other health care facility, for out-patient use; or (iii) a pharmacy or pharmacist licensed by the Board of Pharmacy, but situated outside this state for delivery to a person residing in this state, the medical services provider, health care facility, pharmacist or pharmacy shall, in a manner prescribed by rules promulgated by the Board of Pharmacy under this article, report the following information, as applicable:
(1) The name, address, pharmacy prescription number and Drug Enforcement Administration controlled substance registration number of the dispensing pharmacy or the dispensing physician or dentist;
(2) The full legal name, address and birth date of the person for whom the prescription is written;
(3) The name, address and Drug Enforcement Administration controlled substances registration number of the practitioner writing the prescription;
(4) The name and national drug number of the drug of concern dispensed;
(5) The quantity and dosage of the drug of concern dispensed;
(6) The date the prescription was written and the date filled;
(7) The number of refills, if any, authorized by the prescription;
(8) If the prescription being dispensed is being picked up by someone other than the patient on behalf of the patient, the first name, last name and middle initial, address and birth date of the person picking up the prescription as set forth on the person's government-issued photo identification card shall be retained in either print or electronic form until such time as otherwise directed by rule promulgated by the Board of Pharmacy; and
(9) The source of payment for the controlled substance dispensed.
(b) The penalties set forth in section seven of this article shall not apply to drugs listed as drugs of concern. Failure to report may be considered a violation of the practice act of the prescriber and may result in discipline by the appropriate licensing board.
(c) The Board of Pharmacy may promulgate emergency rules pursuant to the provisions of section fifteen, article three, chapter twenty-nine-a of this code to effectuate the provisions of this section.