WSR 11-05-094

PROPOSED RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed February 16, 2011, 10:05 a.m. ]

Original Notice.

Exempt from preproposal statement of inquiry under RCW 34.05.310(4).

Title of Rule and Other Identifying Information: WAC 246-870-060 What are the board requirements for electronic prescription transmission systems?, amending the rule to include the use of tamper resistant paper and the manual signature of the prescriber.

Hearing Location(s): Department of Health, 310 Israel Road S.E., Room 152/153, Tumwater, WA 98501, on April 7, 2011, at 1:00 p.m.

Date of Intended Adoption: April 7, 2011.

Submit Written Comments to: Doreen E. Beebe, Washington State Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-2901, by March 31, 2011.

Assistance for Persons with Disabilities: Contact Doreen E. Beebe by April 4, 2011, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule change will amend WAC 246-870-060(6) to require the prescriber to manually sign the hard copy of a prescription printed from an electronic prescription transmission system. The change will make the rule language consistent with the tamper-resistant prescription law (RCW 18.64.500).

Reasons Supporting Proposal: The current rule as written is in conflict with chapter 328, Laws of 2009, HB 2014. The law, effective July 1, 2010, requires that if a hard copy of an electronically generated prescription is given directly to the patient, the prescription must be manually signed and must be on approved tamper-resistant paper.

Statutory Authority for Adoption: RCW 18.64.005.

Statute Being Implemented: RCW 18.64.500.

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

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

Name of Agency Personnel Responsible for Drafting: Doreen E. Beebe, 310 Israel Road S.E., Tumwater, WA 98501, (360) 236-4834; Implementation and Enforcement: Susan Teil Boyer, 310 Israel Road S.E., Tumwater, WA 98501, (360) 236-4853.

No small business economic impact statement has been prepared under chapter 19.85 RCW. Under RCW 19.85.025 and 34.05.310 (4)(e), a small business economic impact statement is not required for a proposed rule where the content of the rule is explicitly and specifically dictated by statute.

A cost-benefit analysis is not required under RCW 34.05.328. The agency did not complete a cost-benefit analysis under RCW 34.05.328. RCW 34.05.328 (5)(b)(v) exempts rules the content of which is explicitly and specifically dictated by statute.

February 16, 2011

Susan Teil Boyer

Executive Director

OTS-3141.5


AMENDATORY SECTION(Amending WSR 03-24-070, filed 12/1/03, effective 1/1/04)

WAC 246-870-060   What are the board requirements for electronic prescription transmission systems?   (1) Systems for the electronic transmission of prescription information must be approved by the board. Board approval of systems will be for a period of three years. The board will maintain a list of approved systems.

(2) Systems in which prescriptions are transmitted from the prescriber's facsimile machine to the pharmacy facsimile machine do not require board approval.

(3) Each system shall have policies and procedures on the electronic transmission of prescription information available that address the following:

(a) Patient access. The system may not restrict the patient's access to the pharmacy of their choice.

(b) Security. The system shall have security and system safeguard designed to prevent and detect unauthorized access, modification, or manipulation of prescription information. Accordingly, the system should include:

(i) Documented formal procedures for selecting and executing security measures;

(ii) Physical safeguards to protect computer systems and other pertinent equipment from intrusion;

(iii) Processes to protect, control and audit access to confidential patient information; and

(iv) Processes to prevent unauthorized access to the data when transmitted over communication networks or when data physically moves from one location to another using media such as magnetic tape, removable drives or CD media.

(c) Systems that utilize intermediaries in the electronic communication or processing of prescriptions such as third party payers shall be responsible to insure that their contracts with these intermediaries require security measures that are equal to or better than those provided by this rule and prohibit the modification of any prescription record after it has been transmitted by the practitioner to the pharmacist.

(d) Confidentiality of patient records. The system shall maintain the confidentiality of patient information in accordance with the requirements of chapters 18.64, 69.50, and 70.02 RCW Health Care Information Act and any applicable federal law.

(e) Authentication. To be valid prescriptions transmitted by an authorized prescriber from computer to fax machine or from computer to computer must use an electronic signature or digital signature.

(4) The system shall provide for the transmission and retention of the information by the sender and the receiver of the prescription as required in WAC 246-870-030.

(5) The system must authenticate the sender's authority and credentials to transmit a prescription.

(a) The system shall provide an audit trail of all prescriptions electronically transmitted that documents for retrieval all actions and persons who have acted on a prescription, including authorized delegation of transmission;

(b) The right of the Washington state board of pharmacy to access electronically submitted prescriptions for purposes of investigations in disciplinary proceedings.

(6) If a hard copy of an electronic prescription((, generated from the electronic prescription system, is printed on security paper that insures it is not subject to copying or alteration, an electronic signature may be substituted for a manual signature)) is given directly to the patient, the prescription must be printed on approved tamper-resistant paper and must be manually signed by the prescriber as required in RCW 18.64.500.

[Statutory Authority: Chapters 69.41, 69.50 RCW, RCW 18.64.005. 03-24-070, 246-870-060, filed 12/1/03, effective 1/1/04.]

Washington State Code Reviser's Office