Rule-making notices
Notice of Hearing
Pharmacy Examining Board
Hearing Date, Time and Location
Date: September 7, 2005
Time: 9:30 A.M.
Location: 1400 East Washington Avenue
Room 179A
Madison, Wisconsin
Appearances at the Hearing
Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may also be submitted in writing without a personal appearance by mail addressed to the Department of Regulation and Licensing, Office of Legal Counsel, 1400 East Washington Avenue, Room 171, P.O. Box 8935, Madison, Wisconsin 53708. Comments must be received on or before September 19, 2005, to be included in the record of rule-making proceedings.
Analysis prepared by the Department of Regulation and Licensing.
Explanation of agency authority: The Wisconsin Pharmacy Examining Board is granted the authority to protect the public health, safety and welfare by establishing minimum standards for the practice of pharmacy. The practice of pharmacy includes creating and maintaining accurate records and the transfer of prescription order information.
Related statute or rule: Current Wis. Admin. Code s.
Phar 7.05
Plain language analysis: The purpose of the proposed rule change is to provide greater clarity to guide pharmacists to differentiate between requirements for prescription recordkeeping generally versus the transfer of prescription order information. The use of a computer system for both purposes has components in common, but contain differences and limitations. The interplay of federal law was also more explicitly recognized by listing the additional requirements for the transfer of prescription order information necessary to comply with federal law.
SECTION 1 renumbers a section of the current rule regarding the period of time that pharmacy records must be kept and amends the rule to create consistent language usage between federal and state administrative rules.
SECTION 2 repeals sections of the current rule regarding the transfer of prescription order information.
SECTION 3 renumbers a section of the current rule and amends the rule to create consistent language usage between federal and state administrative rules and to segregate the requirements for general pharmacy recordkeeping.
SECTION 4 creates a new section to specify the requirements for the transfer of prescription order information. The requirements are delineated into four separate subsections; general requirements, non-controlled substances, controlled substances and the use of a computer system. The general requirements subsection applies to all transfers of prescription order information performed either verbally or by the use of a computer system, including the requirement that a pharmacist making a transfer or receiving a transfer must be licensed in the state in which they perform an act required to accomplish the transfer. The requirements subsection for non-controlled substances specifically delineates the information that must be recorded by the transferring and receiving pharmacist. The requirements subsection for controlled substances adds additional requirements for information to be recorded that is required by federal law.
Summary of factual data and analytical methodologies: The Pharmacy Examining Board reviewed adjacent state rules and federal law to determine how the impact of technology was influencing the practice of transferring prescription order information. The board became aware that greater clarity was needed to provide practice guidance to pharmacists to differentiate between prescription recordkeeping generally versus the transfer of prescription order information which uses and creates records. The use of a computer system for both purposes had become clouded in the rule in its present form as the rule had been amended piecemeal during the course of past years. Therefore, the board chose to repeal and recreate part of the rule related to the transfer of prescription order information, and to separate and update the current rule relating to the use of computer systems to maintain records generally in a pharmacy.
Anticipated costs incurred by private sector: The department finds that this rule has no significant fiscal effect on the private sector.
Fiscal estimate
The proposed rule will have minimal impact on the department's funds. The department will expend some training time and resources to update inspectors on these recordkeeping requirements.
Effect on small business
These proposed rules will be reviewed by the department's small business review advisory committee to determine whether they will have a significant economic impact on a substantial number of small businesses, as defined in s.
227.114 (1), Stats. The Department's Regulatory Review Coordinator may be contacted by email at
larry.martin@drl.state.wi.us, or by calling (608) 266-8608.
Agency contact person
Pamela Haack, Department of Regulation and Licensing, Office of Legal Counsel, 1400 East Washington Avenue, Room 171, P.O. Box 8935, Madison, Wisconsin 53708-8935. Telephone: (608) 266-0495. Email:
pamela.haack@drl.state.wi.us.
Place where comments are to be submitted and deadline for submission: Comments may be submitted to Pamela Haack, Department of Regulation and Licensing, 1400 East Washington Avenue, Room 171, P.O. Box 8935, Madison, Wisconsin 53708-8935, or by email at
pamela.haack@drl.state.wi.us. Comments must be received on or before September 19, 2005 to be included in the record of rule-making proceedings.
TEXT OF RULE
SECTION 1. Phar 7.05 (1) is renumbered Phar 7.05 (1m) and as renumbered is amended to read:
Phar 7.05 (1m) A record of all prescriptions dispensed shall be maintained for a period of 5 years after the date of the last renewal refill.
SECTION 2. Phar 7.05 (3) to (5) and the Note following 7.05 (5) are repealed.
SECTION 3. Phar 7.05 (6) is renumbered Phar 7.05 (1) and as renumbered Phar 7.05 (1) (intro.) and (b) are amended to read:
Phar 7.05 (1) (intro.) A computerized system may be used for maintaining a record required of prescription dispensing and transfers of prescription order information for the purposes of original or renewal refill dispensing if the system:
(b) Is equipped with an auxiliary procedure which, during periods of down-time, shall be used for documentation of prescription dispensing. The auxiliary procedure shall ensure that prescription renewals refills are authorized by the original prescription order, that the maximum number of prescription renewals refills has not been exceeded and that all of the appropriate data are retained for on-line entry as soon as the computer system is again available for use.
SECTION 4. Phar 7.055 is created to read:
Phar 7.055 Transfer of prescription order information. (1) GENERAL REQUIREMENTS. The transfer of prescription order information for the purpose of original or refill dispensing is permissible between pharmacies licensed in this state or another state pursuant to the following general requirements:
(a) The transfer shall be communicated directly between 2 pharmacists either by verbal transfer or by a computer system transfer meeting the requirements of sub. (4). Communication by facsimile machine is not allowed unless the prescription order information being transferred is verified verbally between 2 pharmacists.
(b) If a verbal transfer of prescription order information is performed for a non-controlled substance, the pharmacist making the transfer may record the information required by sub. (2) on a computer system meeting the requirements of s.
Phar 7.05 (1) (a) and
(b).
(c) The pharmacist receiving the verbal transfer of prescription order information for either a controlled or a non-controlled substance shall record the transferred information in writing unless a computer system transfer meeting the requirements of sub. (4) is used.
(d) All original and transferred prescription orders shall be maintained for a period of 5 years from the date of the last refill.
(e) A written copy of any prescription order for a prescribed drug provided by a pharmacist shall be identified in writing as “COPY – FOR INFORMATION ONLY." No prescribed drug may be dispensed based on an information copy.
(f) A pharmacist making or receiving a transfer of prescription order information shall be licensed in the state in which they perform an act required by this section.
(2) NON-CONTROLLED SUBSTANCES. The transfer of prescription order information for non-controlled substances for the purposes of original or refill dispensing is permissible pursuant to the following requirements:
(a) The pharmacist making the transfer records the following information:
1. The word “VOID" is written on the face of the invalidated prescription order or recorded in a similar manner to “VOID" a prescription order in a computer system meeting the requirements of s.
Phar 7.05 (1) (a) and
(b).
2. The name and address of the pharmacy to which it was transferred, the name of the pharmacist receiving the prescription order, the date and the name of the pharmacist transferring the information are recorded on the reverse side of the invalidated prescription order or in a computer system meeting the requirements of s.
Phar 7.05 (1) (a) and
(b).
3. A transfer of prescription order information for a non-controlled substance for the purposes of refill dispensing is limited to the number of authorized refills.
(b) The pharmacist receiving the transferred prescription order information shall record in writing the following:
1. The word “TRANSFER" on the face of the transferred prescription order.
2. The name and address of the patient, the name and address of the prescribing practitioner, and the name and quantity and dosage form of the drug product or device prescribed and the directions for use.
3. The date of issuance of the original prescription order.
4. The original number of refills authorized on the original prescription order.
5. The date of original dispensing if the prescription order has previously been dispensed.
6. The number of valid refills remaining and the date of the last refill.
7. The pharmacy's name, address, and the prescription order number from which the prescription order information was transferred.
8. The name of the pharmacist making the transfer.
9. The name, address and telephone number of the pharmacy from which the original prescription order was transferred if different than subd. 7.
(3) CONTROLLED SUBSTANCES. The transfer of prescription order information for controlled substances for the purposes of refill dispensing is permissible pursuant to the following requirements:
(a) The transfer of prescription order information is permissible only on a one time basis unless a computer system meeting the requirements of sub. (4) is used.
