The objective of this proposed rule is to specify the requirements for an approved central fill system. Integrated health systems, business entities comprising common ownership of multiple pharmacies and pharmacies desiring to enter contractual relationships with outside vendors have an interest in increasing patient convenience and lowering cost of service based upon the central filling of prescription orders for dispensing. The intent of such rules is to preserve the integrity of the dispensing process by addressing the issues of ownership of inventory, patient confidentiality, consultation, security, accuracy and accountability which must be maintained in any approved central fill system.
A “central fill pharmacy" is defined as a pharmacy licensed in this state acting as an agent of an originating pharmacy to fill or refill a prescription order. The “originating pharmacy" is a pharmacy licensed in this state that uses a central fill pharmacy to fill or refill a prescription order for purposes of dispensing by the originating pharmacy.
The central fill pharmacy and originating pharmacy may only process a request for the filling or refilling of a prescription received by an originating pharmacy when the requirements of this section are met. The central fill pharmacy must either have the same owner as the originating pharmacy or a contract with the originating pharmacy outlining the services, responsibilities and accountabilities of each pharmacy. Also, both pharmacies must maintain a written protocol delineating each pharmacy's assumption of responsibility for compliance with the prescription drug compounding and dispensing requirements of chs.
Phar 7 and
8. The proposed rule provides that the originating pharmacy shall still remain responsible for compliance with the prescription drug compounding and dispensing requirements of chs.
Phar 7 and
8 which are not assumed in writing by the central fill pharmacy pursuant to a filling protocol. The originating pharmacy will always remain solely responsible for the patient consultation and transfer requirements of s.
Phar 7.01 (1) (e) and
(em) where the prescription drug is not delivered by an agent of the pharmacist to a patient's residence. Certain functions in the dispensing process may not be performed by the central fill pharmacy unless it shares a common central processing unit with the originating pharmacy. These functions are the medication profile record review of the patient, drug utilization review, claims adjudication, refill authorizations, interventions, drug interactions and selection of drug product equivalents. The originating pharmacy remains responsible for original recordkeeping of all prescription orders as required by state and federal law. All original and refill requests received by the central fill pharmacy are required to be treated as prescription orders for purposes of filing and recordkeeping as required by state and federal law. Each pharmacy is required to maintain duplicate records to identify each pharmacist responsible for receiving and reviewing prescription orders and compounding and dispensing pursuant to a prescription order and to track the prescription order during each step in the dispensing process. Both pharmacies are required to adopt a joint written quality assurance program to monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, resolve identified problems and insure compliance with this section. The label of any prescription drug container dispensed is also required to contain an additional label encoding either electronically or in printed form the name and address of the central fill pharmacy, the name of the pharmacist who filled the prescription order, and the date of filling.
Text of Rule
SECTION 1. Phar 7.12 is created to read:
Phar 7.12 Central fill pharmacy. (1) As used in this section, “central fill pharmacy" means a pharmacy licensed in this state acting as an agent of an originating pharmacy to fill or refill a prescription.
(2) As used in this section, “originating pharmacy" means a pharmacy licensed in this state that uses a central fill pharmacy to fill or refill a prescription order.
(3) A central fill pharmacy and originating pharmacy may process a request for the filling or refilling of a prescription received by an originating pharmacy only pursuant to the following requirements:
(a) The central fill pharmacy either has the same owner as the originating pharmacy or has a contract with the originating pharmacy outlining the services to be provided and the responsibilities and accountabilities of each pharmacy in fulfilling the terms of the contract in compliance with federal and state law.
(b) The central fill pharmacy and originating pharmacy maintain a written filling protocol delineating each pharmacy's assumption of responsibility for compliance with the prescription drug compounding and dispensing requirements of chs.
Phar 7 and
8.
(c) The originating pharmacy shall remain responsible for compliance with the prescription drug compounding and dispensing requirements of ch.
Phar 7 and which are not assumed in writing by the central fill pharmacy pursuant to such protocol.
(d) The central fill pharmacy shall not assume and the originating pharmacy shall at all times remain solely responsible to perform and comply with the requirements of s.
Phar 7.01 (1) (e) and
(em) in instances where the prescription is not delivered by an agent of the pharmacist to a patient's residence.
(e) Unless the central fill pharmacy shares a common central processing unit with the originating pharmacy it may not perform processing functions such as, the medication profile record review of the patient, drug utilization review, claims adjudication, refill authorizations, interventions, drug interactions and selection of drug product equivalents.
(f) The originating pharmacy shall maintain the original of all prescription orders received for purposes of filing and recordkeeping as required by state and federal law.
(g) The central fill pharmacy shall maintain all original fill and refill requests received from the originating pharmacy and shall treat them as original and refill prescription orders for purposes of filing and recordkeeping as required by state and federal law.
(h) In addition to meeting the other recordkeeping requirements required by state and federal law, the central fill pharmacy and originating pharmacy shall maintain duplicate records to identify each pharmacist responsible for receiving and reviewing prescription orders and compounding and dispensing pursuant to a prescription order and track the prescription order during each step in the dispensing process.
(i) The central fill pharmacy and originating pharmacy shall adopt a written quality assurance program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, resolve identified problems and insure compliance with this section.
(j) In addition to meeting the requirements of s.
450.11 (4), Stats., every container of a prescription drug dispensed pursuant to this section shall contain an additional label encoding either electronically or in printed form the name and address of the central fill pharmacy, the name of the pharmacist who filled the prescription order, and the date of filling.
Fiscal Estimate
1. The anticipated fiscal effect on the fiscal liability and revenues of any local unit of government of the proposed rule is: $0.00.
2. The projected anticipated state fiscal effect during the current biennium of the proposed rule is: $0.00.
3. The projected net annualized fiscal impact on state funds of the proposed rule is: $0.00.
Initial Regulatory Flexibility Analysis
These proposed rules will be reviewed by the department through its Small Business Review Advisory Committee to determine whether there will be an economic impact on a substantial number of small businesses, as defined in s.
227.114 (1) (a), Stats.
Copies of Rule and Contact Person
Copies of this proposed rule are available without cost upon request to: Pamela Haack, Department of Regulation and Licensing, Office of Administrative Rules, 1400 East Washington Avenue, Room 171, P.O. Box 8935, Madison, Wisconsin 53708 (608) 266-0495.
Notice of Hearing
Pharmacy Examining Board
NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Pharmacy Examining Board in ss.
15.08 (5) (b),
227.11 (2),
450.02 (3) (e),
450.03 (2) and
450.04 (1), Stats and interpreting ss.
450.04 and
450.05, Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to amend s.
Phar 2.01 (1) and
2.04 (1), relating to examinations for original licensure and for persons licensed in another state.
Hearing Date, Time and Location
Date: September 11, 2001
Time: 9:15 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 Administrative Rules, P.O. Box 8935, Madison, Wisconsin 53708. Written comments must be received by September 25, 2001 to be included in the record of rule-making proceedings.
Analysis prepared by the Department of Regulation and Licensing
The objective of this proposed rule-making order is to create consistent licensure requirements with other states that require applicants in certain instances to take and pass the Foreign Pharmacy Graduate Equivalency Examination (FPGEE), the Test of English as a Foreign Language (TOEFL), and the Test of Spoken English (TSE).
Currently, Wisconsin law only requires that an applicant who is a foreign graduate of a school of pharmacy to take and pass the Foreign Pharmacy Graduate Equivalency Examination (FPGEE), offered by the National Association of Boards of Pharmacy, Foreign Pharmacy Graduate Examination Committee (FPGEC). Other states require a foreign graduate of a school of pharmacy to take and pass three examinations, the Foreign Pharmacy Graduate Equivalency Examination (FPGEE), the Test of English as a Foreign Language (TOEFL), and the Test of Spoken English (TSE). Upon successfully taking and passing all three examinations the foreign graduate earns FPGEC Certification. Requiring foreign graduate applicants in Wisconsin to earn FPGEC Certification as a precondition for licensure will allow Wisconsin licensure requirements in this instance to be considered “substantially equivalent" with other states, thus allowing greater mobility for pharmacists with Wisconsin licensure who thereafter seek licensure in other states.
Text of Rule
SECTION 1. Phar 2.01 (1) is amended to read:
Phar 2.01 (1) Has been graduated from a school or college of pharmacy approved by the board or has taken and passed the foreign pharmacy graduate equivalency examination given obtained certification by the foreign pharmacy graduate examination commission committee.
SECTION 2. Phar 2.04 (1) is amended to read:
Phar 2.04 (1) Has been graduated from a school or college of pharmacy approved by the board, or has taken and passed the foreign pharmacy graduate equivalency examination given obtained certification by the foreign pharmacy graduate examination commission committee.
Fiscal Estimate
1. The anticipated fiscal effect on the fiscal liability and revenues of any local unit of government of the proposed rule is: $0.00.
2. The projected anticipated state fiscal effect during the current biennium of the proposed rule is: $0.00.
3. The projected net annualized fiscal impact on state funds of the proposed rule is: $0.00.
Initial Regulatory Flexibility Analysis
These proposed rules will be reviewed by the department through its Small Business Review Advisory Committee to determine whether there will be an economic impact on a substantial number of small businesses, as defined in s.
227.114 (1) (a), Stats.
Copies of Rule and Contact Person
Copies of this proposed rule are available without cost upon request to: Pamela Haack, Department of Regulation and Licensing, Office of Administrative Rules, 1400 East Washington Avenue, Room 171, P.O. Box 8935, Madison, Wisconsin 53708 (608) 266-0495.
Notice of Proposed Rule-Making
Revenue
NOTICE IS HEREBY GIVEN that pursuant to ss.
227.11 (2),
565.01 (4) to
(4g) and
565.10, Stats., and interpreting ss.
565.01 (4),
565.10,
565.12,
565.25 and
565.30, Stats., and according to the procedure set forth in s.
227.16 (2) (e), Stats., the Department of Revenue will adopt the following rule as proposed in this notice, without public hearing unless, within 30 days after publication of this notice,
August 15, 2001, the Department of Revenue is petitioned for a public hearing by 25 natural persons who will be affected by the rule; a municipality who will be affected by the rule; or an association which is representative of a farm, labor, business or professional group which will be affected by the rule:
Analysis prepared by the Department of Revenue
The proposed order is intended to improve chs.
Tax 61,
62 and
63 by updating various definitions and terminology, clarifying various provisions, reflecting proper format and providing statutory references throughout the chapters. Additionally, the Wisconsin Lottery is proposing a change in the way in which nonprofit retailer contracts are administered. This change results in a potential for savings to taxpayers in administrative labor and data management activities, as well as allowing for the improvement of Lottery customer service to nonprofit retailers.
SECTIONS 1, 2, 6, 7, 8, 9, 11, 12, 15, AND 25. Tax 61.01, 61.02 (2), 61.04 (1) (intro.), (a) and (e), (3) and (4), 61.05 (1), 61.06(2) and (4), 61.07, 61.09, 61.10, 62.01, 63.01, 63.07 and 63.08 are revised, to update terminology and to reflect proper language and punctuation per Legislative Council Rules Clearinghouse (Clearinghouse) standards.
SECTION 3. Tax 61.02 (3) is repealed, because the term “executive director" is obsolete.
SECTION 4. As a result of the repeal of Tax 61.02 (3), Tax 61.02 (4) to (10) are renumbered Tax 61.02 (3) to (9). As renumbered, subs. (6), (7) and (9) are revised, to update terminology and to reflect proper language and punctuation per Clearinghouse standards.
SECTION 5. Tax 61.03 (1) is revised, to place a mailing address and location in a note rather than in the text of the rule, per Clearinghouse standards.
Tax 61.03 (2) is revised, to update terminology and to provide further clarification of the subsection.
SECTION 10. Tax 61.08 (1), (3), (5), (7), (8), (10), (11) (b) and (e), (13), (14) (b), (bm), (c) and (d), (15), (16), (19), (20) and (21) (intro.) and (a) to (h) are revised, to update terminology and to reflect proper language and punctuation per Clearinghouse standards.
Tax 61.08 (11) (h) is revised, to reflect that it is no longer necessary, but it is permissible, to stamp lottery tickets. Tax 61.08 (15) (c) and (d) are repealed, to remove code that is outdated due to changes in computer-monitored pack return procedures. Tax 61.08 (15) (d) is revised, to eliminate the authority to accept returned packs of tickets for credit after the last date on which it is permitted to sell those tickets.
SECTION 13. Tax 62.02 is repealed and recreated, to add additional definitions relevant to ch. Tax 62.
SECTION 14. Tax 62.20 is revised, to update terminology, to reflect proper punctuation per Clearinghouse standards and to provide further clarification of the subsection.
SECTION 16. Tax 63.02 is repealed and recreated, to add an introduction, to delete obsolete definitions, to add a new definition, to update language and punctuation per Clearinghouse standards, and to revise the definition of “Wisconsin lottery" to reference Tax 61.02 (9).
SECTION 17. Tax 63.03 (1) is revised, to update terminology and to place a mailing address and location in a note rather than in the text of the rule, per Clearinghouse standards.
Tax 63.03 (2) is revised, to update terminology and to provide further clarification of the subsection.
SECTIONS 18, 19 AND 20. Tax 63.04 (1) is revised, Tax 63.04 (2) (intro.) is renumbered Tax 63.04 (2) and revised, and Tax 63.04 (2) (a) and (b) are repealed, to more properly reflect the scope of a certificate of authority, in compliance with s. 565.10 (12), Stats. This significantly improves the method for administering non-profit retailer contracts while generating savings in cost and time for both the lottery and non-profit organizations. The limits of 26 events and 1 special event or of 2 special events per retailer are repealed, and replaced by administrative control on the locations at which a non-profit may conduct events for the 3-year duration of a contract. This proposed change results in operational efficiency for the lottery. It also allows non-profit retailers the opportunity to utilize pre-approved alternative locations in a case where unforeseen circumstances such as weather cause a scheduled event or special event to be canceled or relocated.
SECTION 21. Tax 63.04 (3) is revised, to remove an outdated policy relating to charging a fee for obtaining a duplicate certificate of authority.
Tax 63.04 (4) is revised, to update terminology.
Tax 63.04 (5) is revised, to remove fee statements that are no longer applicable and to update procedures relating to amending a retailer contract.
SECTION 22. Tax 63.06 (1), (3), (5), (7), (8) (b), (c) and (d), (9), (10) and (11) (a) are revised, to update terminology and to reflect proper language and punctuation per Clearinghouse standards.
Tax 63.06 (2) is revised, to provide procedures for amending a list of contract locations.
Tax 63.06 (6) is revised, to update language per Clearinghouse standards and to reflect that a certificate is to be displayed at every event or location, not just at every event.
Tax 63.06 (8) (g) is revised, to reflect that it is no longer necessary, but it is permissible, to stamp lottery tickets.
SECTION 23. Tax 63.06 (11) (c) is repealed and recreated, to reflect a change in position that certain lottery tickets may be returned by a retailer, and to indicate the circumstances under which they may be returned.
SECTION 24. Tax 63.06 (11) (d), (12), (13), (14) and (15) (intro.), (a), (e), (f), (g) and (h) are revised, to update language per Clearinghouse standards and to clarify the manner in which retailers are responsible for redeeming break-open tickets for players.
ALL APPLICABLE SECTIONS. In addition to the revisions described above, notes are added at the end of each section in chs.
Tax 61,
62 and
63, to cite the statutes that each section interprets.
SECTION 1. Tax 61.01 is amended to read:
