WSR 03-24-070

PERMANENT RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed December 1, 2003, 3:55 p.m. ]

Date of Adoption: October 15, 2003.

Purpose: Implement legislation to allow the electronic transfer of prescription information from practitioner's offices to pharmacies and between pharmacies. The rule also implements legislation related to the faxing of prescription information.

Statutory Authority for Adoption: Chapters 69.41, 69.50 RCW, RCW 18.64.005.

Adopted under notice filed as WSR 03-20-106 on October 1, 2003.

Changes Other than Editing from Proposed to Adopted Version: The proposed rule was changed to clarify the intent of the rule. Changes were not substantial.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 1, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 1, Amended 0, Repealed 0.
Effective Date of Rule: Thirty-one days after filing.

November 10, 2003

Susan Teil Boyer

Chair

OTS-6158.2

Chapter 246-870 WAC

ELECTRONIC TRANSMISSION OF PRESCRIPTION INFORMATION


NEW SECTION
WAC 246-870-010   Purpose.   The purpose of this chapter is to ensure compliance with the law on electronic transfer of prescription information and to provide guidance on how compliance can be achieved.

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NEW SECTION
WAC 246-870-020   What definitions do I need to know to understand these rules?   (1) "Electronic transmission of prescription information" means the communication from an authorized prescriber to a pharmacy or from one pharmacy to another pharmacy, by computer, by the transmission of an exact visual image of a prescription by facsimile, or by other electronic means other than electronic voice communication, of original prescription information or prescription refill information for a legend drug or controlled substance consistent with state and federal law.

(2) "Confidential patient information" means information maintained in the patient's health care records or individually identifiable health care records. Confidential information must be maintained and protected from release in accordance with chapter 70.02 RCW and applicable federal law.

(3) "Digital signature" means an electronic identifier that provides for message integrity, nonrepudiation, user authentication, and encryption and is intended to have the force and effect of a manual signature.

(4) "Electronic signature" means an electronic sound, symbol, or process attached to or logically associated with a prescription and executed or adopted by an authorized person with the intent to sign the prescription.

(5) "Security" means a system to maintain the confidentiality and integrity of patient records including:

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

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

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

(d) 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.

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NEW SECTION
WAC 246-870-030   What is included in the electronic transmission and transfer of prescription information?   The electronic transfer of prescription information includes the communication of prescription information by computer, fax, or other electronic means. It includes the transfer of original and refill prescriptions and the transfer of prescription information from one pharmacy to another pharmacy.

Transmission of original prescriptions must include:

(1) Prescriber's name and the physical address of the prescriber;

(2) Prescriber's Drug Enforcement Administration Registration number where required for controlled substance prescriptions;

(3) Date of issuance;

(4) Patient's name and address;

(5) Drug name, dose, route, form, directions for use, quantity;

(6) Electronic, digital, or manual signature of the prescriber;

(7) Refills or renewals authorized, if any;

(8) A place to note allergies and a notation of purpose for the drug;

(9) Indication of preference for a generic equivalent drug substitution;

(10) Any other requirements consistent with laws and rules pertaining to prescription content and form, RCW 69.41.120 and 21 Code of Federal Regulations Part 1300; and

(11) Identification of the electronic system readily retrievable for board of pharmacy inspection.

Transfer of prescription information from pharmacy to pharmacy by facsimile, or verbally, must include:

(a) All elements of the original prescription;

(b) Date of transfer maintained in records at each site;

(c) Number of refills remaining and the date of last refill;

(d) State and federal required information for controlled substances;

(e) No further refills may be issued by the transferring pharmacy unless the pharmacies use a common electronic data base for prescription filling which provides an audit trail to document each refill and limits refills to the number authorized.

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NEW SECTION
WAC 246-870-040   Can all prescriptions be transmitted electronically?   Consistent with state and federal laws and rules over-the-counter, legend drug and controlled substance prescriptions may be transmitted electronically.

Federal and state law do not allow the electronic transfer of Schedule II prescriptions except exact visual images as described in WAC 246-870-050(3). The pertinent requirements for Schedule II prescriptions are found in RCW 69.50.308 and 21 CFR Part 1306.

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NEW SECTION
WAC 246-870-050   What are the requirements for fax machines?   Prescription orders may be transmitted to pharmacists directly from the prescriber using facsimile transmission devices subject to the following requirements:

(1) The order contains the date, time, and telephone number and location of the transmitting device.

(2) Prescriptions for Schedule III, IV, and V drugs may be transmitted at any time.

(3) Prescriptions for Schedule II drugs may be transmitted only under the following conditions:

(a) The order is for an injectable Schedule II narcotic substance that is to be compounded by the pharmacist for patient use; or

(b) The prescription is written for patients in a long-term care facility or a hospice program as defined in RCW 69.50.308;

(c) The prescription must be signed by the prescriber;

(d) In a nonemergent situation, an order for Schedule II controlled substances may be prepared for delivery to a patient pursuant to a facsimile transmission but may not be dispensed to the patient except upon presentation of a written order;

(e) In an emergent situation, an order for Schedule II controlled substances may be dispensed to the patient upon the oral prescription of a prescriber subject to the requirements of RCW 69.50.308(c). The pharmacy has seven days to obtain a written prescription that covers an emergency Schedule II oral prescription;

(f) To a hospital as defined in WAC 246-873-010 for a patient admitted to or being discharged from the hospital.

(4) The transmitted order shall be filed in the same manner as any other prescription. However, the pharmacist is responsible for assuring that the quality of the order is sufficient to be legible for at least two years pursuant to the records retention requirements of WAC 246-869-100.

(5) Refill authorizations for prescriptions may be electronically transmitted.

(6) The pharmacist is responsible for assuring that each electronically transmitted prescription is valid and shall verify authenticity with the prescriber whenever there is a question.

(7) No agreement between a prescriber and a pharmacist or pharmacy shall require that prescription orders be electronically transmitted from the prescriber to only that pharmacy.

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NEW SECTION
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 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.

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NEW SECTION
WAC 246-870-070   What are the board requirements for pharmacies using electronic prescription transmission systems?   Each pharmacy must have policies and procedures that ensure the integrity and confidentiality of patient information transmitted electronically as required by chapter 70.02 RCW and applicable federal law. All pharmacy employees and agents of the pharmacy are required to read, sign and comply with the policy and procedures.

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NEW SECTION
WAC 246-870-080   Can prescription records be stored electronically?   Prescription records for legend drugs can be stored electronically if they are in compliance with chapter 246-875 WAC patient medication record systems and are readily retrievable by the board, or its agent for inspection. Controlled substance prescriptions must be maintained in accordance with state and federal regulations.

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NEW SECTION
WAC 246-870-090   Can electronic mail systems be used to transmit patient information?   Electronic mail systems can be used to transmit patient information concerning an original prescription or information concerning a prescription refill if all direct communications between a pharmacist and a practitioner are kept secure and confidential. The system used to communicate patient information shall meet the requirements for security and confidentiality in WAC 246-870-020.

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