WSR 24-16-119
PERMANENT RULES
DEPARTMENT OF HEALTH
[Filed August 5, 2024, 2:02 p.m., effective September 5, 2024]
Effective Date of Rule: Thirty-one days after filing.
Purpose: The department of health (department) is adopting clarifying terms and adding definitions of "delivery," "dispense," and "ultimate user." After receiving questions and comments from interested parties around definitions of "dispense" and "distributed" during a state auditor's office audit of the prescription monitoring program (PMP), as well as in various other routine operational situations, the department determined clarification of the rule was necessary. The department is adopting solutions to those questions and concerns through the rule-making process. The department is also adopting language to clarify the prescribers ability to request the history of prescriptions the prescribers have written. Clarifying and defining phrases found in rule is necessary to cut down on confusion regarding requirements of dispensers and prescribers.
Citation of Rules Affected by this Order: Amending WAC 246-470-010, 246-470-030, and 246-470-050.
Adopted under notice filed as WSR 24-11-119 on May 21, 2024.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's own Initiative: New 0, Amended 3, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 3, Repealed 0.
Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 3, Repealed 0.
Date Adopted: August 5, 2024.
Kristin Peterson, JD
Chief of Policy
for Umair A. Shah, MD, MPH
Secretary
OTS-5231.3
AMENDATORY SECTION(Amending WSR 18-17-048, filed 8/8/18, effective 9/8/18)
WAC 246-470-010Definitions.
The definitions in this section apply throughout this chapter unless the context clearly indicates otherwise:
(1) "Authentication" means information, electronic device, or certificate provided by the department or their designee to a data requestor to electronically access prescription monitoring information. The authentication may include, but is not limited to, a user name, password, or an identification electronic device or certificate.
(2) "Controlled substance" has the same meaning provided in RCW
69.50.101.
(3) "Delivery" means the actual or constructive transfer from one person to another of a schedule II, III, IV, or V controlled substance or other drug identified by the pharmacy quality assurance commission in WAC 246-470-020 whether or not there is an agency relationship.
(4) "Department" means the department of health.
(((4)))(5) "Dispense," "dispensing," and "dispensed" means:
(a) The interpretation of a prescription for a schedule II, III, IV, or V controlled substance or other drug identified by the pharmacy quality assurance commission in WAC 246-470-020;
(b) Pursuant to that prescription, the proper selection, measuring, compounding, labeling, or packaging necessary to prepare that prescription for delivery; and
(c) The drug has left the possession of the dispenser because it has been delivered to the ultimate user, or the drug has been provided to a common or contract carrier for delivery to the ultimate user.
(6) "Dispenser" means a practitioner or pharmacy that delivers to the ultimate user a schedule II, III, IV, or V controlled substance or other drugs identified by the pharmacy quality assurance commission in WAC 246-470-020, but does not include:
(a) A practitioner or other authorized person who only administers, as defined in RCW
69.41.010, a controlled substance or other drugs identified by the pharmacy quality assurance commission in WAC 246-470-020;
(b) A licensed wholesale distributor or manufacturer, as defined in chapter
18.64 RCW, of a controlled substance or other drugs identified by the pharmacy quality assurance commission in WAC 246-470-020; or
(c) A veterinarian licensed under chapter
18.92 RCW. Data submission requirements for veterinarians are included in WAC 246-470-035.
(((5)))(7) "Indirect patient identifiers" means data that may include: Hospital or provider identifiers; a five-digit zip code, county, state, and country of residence; dates that include month and year; age in years; and race and ethnicity; but does not include the patient's first name; middle name; last name; Social Security number; control or medical record number; zip code plus four digits; dates that include day, month, and year; or admission and discharge date in combination.
((
(6)))
(8) "Local health officer" means the legally qualified physician who has been appointed as the health officer for a county or district health department, consistent with RCW
70.05.010(2).
((
(7)))
(9) "Qualifying medical test site" means a medical test site licensed by the department under chapter
70.42 RCW, and certified as a drug testing laboratory by the United States department of health and human services, substance abuse and mental health services administration.
(((8)))(10) "Patient" means the person or animal who is the ultimate user of a drug for whom a prescription is issued or for whom a drug is dispensed.
(((9)))(11) "Patient address" means the current geographic location of the patient's residence. If the patient address is in care of another person or entity, the address of that person or entity is the "patient address" of record. When alternate addresses are possible, they must be recorded in the following order of preference:
(a) The geographical location of the residence, as would be identified when a telephone is used to place a 9-1-1 call; or
(b) An address as listed by the United States Postal Service; or
(c) The common name of the residence and town.
(((10)))(12) "Pharmacist" means a person licensed to engage in the practice of pharmacy.
(((11)))(13) "Prescriber" means a licensed health care professional with authority to prescribe controlled substances or legend drugs.
(((12)))(14) "Prescription monitoring information" means information submitted to and maintained by the prescription monitoring program.
((
(13)))
(15) "Program" means the prescription monitoring program established under chapter
70.225 RCW.
(((14)))(16) "Ultimate user" means an individual who lawfully possesses a schedule II, III, IV, or V controlled substance or other drug identified by the pharmacy quality assurance commission in WAC 246-470-020 for the individual's own use or for the use of a member of the individual's household or for administering to an animal owned by the individual or by a member of the individual's household.
(17) "Valid photographic identification" means:
(a) A driver's license or instruction permit issued by any United States state or province of Canada. If the patient's driver's license has expired, the patient must also show a valid temporary driver's license with the expired card.
(b) A state identification card issued by any United States state or province of Canada.
(c) An official passport issued by any nation.
(d) A United States armed forces identification card issued to active duty, reserve, and retired personnel and the personnel's dependents.
(e) A merchant marine identification card issued by the United States Coast Guard.
(f) A state liquor control identification card. An official age identification card issued by the liquor control authority of any United States state or Canadian province.
(g) An enrollment card issued by the governing authority of a federally recognized Indian tribe located in Washington, if the enrollment card incorporates security features comparable to those implemented by the department of licensing for Washington drivers' licenses and are recognized by the liquor control board.
AMENDATORY SECTION(Amending WSR 21-11-088, filed 5/18/21, effective 6/18/21)
WAC 246-470-030Data submission requirements for dispensers.
(1) A dispenser shall provide to the department the dispensing information required by RCW
70.225.020 and this section for all scheduled II, III, IV, and V controlled substances and for drugs identified by the pharmacy quality assurance commission under WAC 246-470-020. Only drugs dispensed for more than one day use must be reported.
(2) Dispenser identification number. A dispenser shall acquire and maintain an identification number issued to dispensing pharmacies by the National Council for Prescription Drug Programs or a prescriber identifier issued to authorized prescribers of controlled substances by the Drug Enforcement Administration, United States Department of Justice.
(3) Submitting data. A dispenser shall submit data to the department electronically, as soon as readily available, but no later than one business day from the date of dispensing a drug, and in the format required by the department. When the dispenser has not dispensed any drugs during a business day which require reporting, then within seven days the dispenser shall report that no drugs requiring reporting were dispensed. The notification shall be in a format established by the department.
(a) A dispenser shall submit ((for each dispensing)) the following information ((and))for each drug dispensed as well as any additional information required by the department:
(i) Patient identifier. A patient identifier is the unique identifier assigned to a particular patient by the dispenser;
(ii) Name of the patient for whom the prescription is ordered including first name, middle initial, last name, and generational suffixes, if any;
(iii) Patient date of birth;
(iv) Patient address;
(v) Patient gender and species code;
(vi) Drug dispensed;
(vii) Date of dispensing;
(viii) Quantity and days supply dispensed;
(ix) Refill and partial fill information;
(x) Prescriber identifiers including the National Provider Identifier and the Drug Enforcement Administration number including any suffix used;
(xi) Prescription issued date;
(xii) Dispenser identifiers including the Drug Enforcement Administration number and the National Provider Identifier;
(xiii) Prescription fill date and number;
(xiv) Source of payment indicated by one of the following:
(A) Private pay (cash, change, credit card, check);
(B) Medicaid;
(C) Medicare;
(D) Commercial insurance;
(E) Military installations and veterans affairs;
(F) Workers compensation;
(G) Indian nations;
(H) Other;
(xv) When practicable, the name of the person picking up or dropping off the prescription as verified by valid photographic identification; and
(xvi) The prescriber's and dispenser's business phone numbers.
(b) A nonresident, licensed pharmacy that ((
delivers))
dispenses controlled substances, as defined in RCW
18.64.360, is required to submit only the transactions for patients with a Washington state zip code.
(c) Data submission requirements do not apply to:
(i) The department of corrections or pharmacies operated by a county for the purpose of providing medications to offenders in state or county correctional institutions who are receiving pharmaceutical services from a state or county correctional institution's pharmacy. A state or county correctional institution's pharmacy must submit data to the program related to each offender's current prescriptions for controlled substances upon the offender's release from a state or county correctional institution.
(ii) Medications provided to patients receiving inpatient services provided at hospitals licensed under chapter
70.41 RCW or patients of such hospitals receiving services at the clinics, day surgery areas, or other settings within the hospital's license where the medications are administered in single doses; or medications provided to patients receiving outpatient services provided at ambulatory surgical facilities licensed under chapter
70.230 RCW.
AMENDATORY SECTION(Amending WSR 18-17-048, filed 8/8/18, effective 9/8/18)
WAC 246-470-050Local health officer, pharmacist, prescriber or other health care practitioner and medical test site access to information from the program.
(1) Access.
(a) The local health officer or a licensed health care practitioner authorized by the local health officer may obtain prescription monitoring information for the purposes of patient follow-up and care coordination following a controlled substance overdose event.
(b) A pharmacist, prescriber, or licensed health care practitioner authorized by a prescriber or pharmacist may obtain prescription monitoring information relating to their patients, for the purpose of providing medical or pharmaceutical care or for the purpose of reviewing the history of prescriptions they wrote.
(c) A qualifying medical test site may have access to prescription monitoring information for the purpose of providing assistance to a prescriber or dispenser for determining medications an identified patient, in the care of the prescriber or dispenser, is taking.
(2) Registration for access.
(a) A local health officer, pharmacist, prescriber, or licensed health care practitioner authorized by a local health officer, prescriber or pharmacist shall register by using the registration process established by the department in order to receive an authentication to access the electronic system.
(b) Staff of a qualifying medical test site, meeting requirements of (a) of this subsection may register for access by using the registration process established by the department.
(3) Verification by the department. The department shall verify the authentication and identity of the local health officer, pharmacist, prescriber, licensed health care practitioner authorized by a local health officer, prescriber or pharmacist, or staff of a qualifying medical test site before allowing access to any prescription monitoring information. The qualifying medical testing laboratory's registered substance abuse and mental health services administration responsible person must designate and report to the program those staff who may access the prescription monitoring information.
(4) Procedure for accessing prescription information.
(a) A local health officer, pharmacist, prescriber, licensed health care practitioner authorized by a local health officer, prescriber or pharmacist, or staff of a qualifying medical test site center may access information from the program electronically, using the authentication issued by the department or the department's designee.
(b) A local health officer, pharmacist, prescriber, or licensed health care practitioner authorized by a local health officer, prescriber or pharmacist may alternately submit a written request via mail or facsimile transmission in a manner and format established by the department.
(5) Reporting lost or stolen authentication. If the authentication issued by the department is lost, missing, or the security of the authentication is compromised, the local health officer, pharmacist, prescriber, licensed health care practitioner authorized by a local health officer, prescriber or pharmacist, or staff of a qualifying medical test site shall notify the department's designee by telephone and in writing as soon as reasonably possible.
(6) All requests for, uses of, and disclosures of prescription monitoring information by authorized persons must be consistent with the mandate as outlined in RCW
70.225.040 and this chapter.