WSR 13-08-067

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed April 1, 2013, 4:43 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 12-14-034.

Title of Rule and Other Identifying Information: Amending WAC 246-470-010 and 246-470-030; and new WAC 246-470-035, prescription monitoring program. Updating the rules to reflect changes in law, including: Adding language to establish alternative data reporting requirements for veterinarians reporting the dispensing of controlled substances to the department of health's prescription monitoring program (PMP); and clarifying that for dispensers other than veterinarians, drugs dispensed for one day use do not need to be reported to the PMP.

Hearing Location(s): Washington State Department of Health, Town Center 2, Room 158, 111 Israel Road S.E., Tumwater, WA 98501, on May 8, 2013, at 11:00 a.m.

Date of Intended Adoption: May 13, 2013.

Submit Written Comments to: Lisa Hodgson, P.O. Box 47852, Olympia, WA 98504-7852, e-mail http://www3.doh.wa.gov/policyreview/, fax (360) 236-4901, by May 8, 2013.

Assistance for Persons with Disabilities: Contact Lisa Hodgson by May 1, 2013, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rules are intended to implement 2012 legislation, SSB 6105 (chapter 192, Laws of 2012). The proposed rules establish alternative PMP data reporting requirements for veterinarians that are related to the animal patient, types of prescriptions that need to be reported, and when the data must be reported. For dispensers other than veterinarians, SSB 6105 changed previous PMP reporting requirements that all controlled substance dispensing must be reported. The bill now requires reporting only drugs dispensed for more than one day use.

Reasons Supporting Proposal: SSB 6105 requires the department, in collaboration with the veterinary board of governors, to establish alternative requirements for veterinarians reporting the dispensing of controlled substances to the PMP. The bill also changed PMP reporting requirements for other dispensers. The proposed rules are needed to implement changes in the PMP law.

Statutory Authority for Adoption: RCW 70.225.025.

Statute Being Implemented: RCW 70.225.020; SSB 6105 (chapter 192, Laws of 2012).

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington state department of health, governmental.

Name of Agency Personnel Responsible for Drafting: Kitty A. Slater, 111 Israel Road S.E., Tumwater, WA 98501, (360) 236-4861; Implementation and Enforcement: Chris Baumgartner, 111 Israel Road S.E., Tumwater, WA 98501, (360) 236-4806.

No small business economic impact statement has been prepared under chapter 19.85 RCW. The proposed rule would not impose more than minor costs on businesses in an industry.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Lisa Hodgson, 111 Israel Road S.E., Tumwater, WA 98501, phone (360) 236-2927, fax (360) 236-4901, e-mail Lisa.Hodgson@doh.wa.gov.

April 1, 2013

Mary C. Selecky

Secretary

OTS-5229.3


AMENDATORY SECTION(Amending WSR 11-16-041, filed 7/27/11, effective 8/27/11)

WAC 246-470-010   Definitions.   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) "Department" means the department of health.

(4) "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 board of pharmacy 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 board of pharmacy in WAC 246-470-020; ((or))

(b) A licensed wholesale distributor or manufacturer, as defined in chapter 18.64 RCW, of a controlled substance or other drugs identified by the board of pharmacy 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) "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.

(6) "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.

(7) "Pharmacist" means a person licensed to engage in the practice of pharmacy.

(8) "Prescriber" means a licensed health care professional with authority to prescribe controlled substances.

(9) "Prescription monitoring information" means information submitted to and maintained by the prescription monitoring program.

(10) "Program" means the prescription monitoring program established under chapter 70.225 RCW.

(11) "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.

[Statutory Authority: Chapter 70.225 RCW and 2007 c 259. 11-16-041, 246-470-010, filed 7/27/11, effective 8/27/11.]

OTS-5097.5


AMENDATORY SECTION(Amending WSR 11-16-041, filed 7/27/11, effective 8/27/11)

WAC 246-470-030   Data 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 board of pharmacy ((pursuant to)) under WAC 246-470-020. Only drugs dispensed for more than one day use must be reported.

(((1))) (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.

(((2))) (3) Submitting data. A dispenser shall submit data to the department electronically, not later than one week from the date of dispensing, and in the format required by the department.

(a) A dispenser shall submit for each dispensing the following information and 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;

(vi) Drug dispensed;

(vii) Date of dispensing;

(viii) Quantity and days supply dispensed;

(ix) Refill information;

(x) Prescriber identifier;

(xi) Prescription issued date;

(xii) Dispenser 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; and

(xv) When practicable, the name of person picking up or dropping off the prescription, as verified by valid photographic identification.

(b) A nonresident, licensed pharmacy that delivers 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.

[Statutory Authority: Chapter 70.225 RCW and 2007 c 259. 11-16-041, 246-470-030, filed 7/27/11, effective 8/27/11.]


NEW SECTION
WAC 246-470-035   Dispensing and data submission requirements for veterinarians.   A veterinarian licensed under chapter 18.92 RCW shall provide to the department the dispensing information required by RCW 70.225.020 and as provided in this section for all schedule II, III, IV and V controlled substances and for drugs identified by the board of pharmacy under WAC 246-470-020.

(1) Dispenser identification number. A veterinarian shall acquire and maintain a prescriber identifier issued to authorized prescribers of controlled substances by the Drug Enforcement Administration, United States Department of Justice.

(2) Submitting data. A veterinarian shall:

(a) Report data for schedule II, III, IV, and V controlled substances, and other required drugs identified by the board of pharmacy under WAC 246-470-020, dispensed for a fourteen-day supply or more;

(b) Report data using either electronic or nonelectronic methods provided by the department;

(c) Submit data quarterly. Data must be reported on the following schedule:


Reporting Period Report Due Date
January - March April 10
April - June July 10
July - September October 10
October - December January 10

(d) Report the following data elements to the department for each schedule II, III, IV, and V controlled substance and other required drugs dispensed for a fourteen-day supply or more:

(i) Name of the animal for whom the drug is dispensed including name of the animal or the animal's species (example: Feline) and the owner's last name;

(ii) Animal's date of birth, or if date of birth is unknown, enter January 1st of the estimated birth year;

(iii) Owner's name including first name, middle initial, last name, and generational suffixes, if any;

(iv) Owner's address;

(v) Drug dispensed;

(vi) Date the drug was dispensed;

(vii) Quantity and days supply dispensed;

(viii) Prescriber identifier;

(ix) Dispenser identifier; and

(x) When practicable, the identification number from a valid photo identification card of the owner.

[]