Phar 7.09(4)(b)
(b) Implementing an ongoing quality assurance program that monitors performance of the automated dispensing system, which is evidenced by written policies and procedures.
Phar 7.09(4)(c)
(c) Providing the board with prior written notice of the installation or removal of an automated dispensing system. The notice provided shall include, but is not limited to the:
Phar 7.09(4)(c)2.
2. Initial location of the automated dispensing system. The automated dispensing system may thereafter be relocated within the pharmacy or inpatient health care facility without providing subsequent notification to the board.
Phar 7.09(4)(d)
(d) Assigning, discontinuing or changing personnel access to the system.
Phar 7.09(4)(e)
(e) Assuring that access to the medications comply with state and federal laws.
Phar 7.09(4)(f)
(f) Assuring that the automated dispensing system is stocked accurately and in accordance with established written policies and procedures.
Phar 7.09(5)
(5) An automated dispensing system shall comply with the following provisions:
Phar 7.09(5)(a)
(a) A pharmacy shall maintain on-site the following documentation relating to an automated dispensing system:
Phar 7.09(5)(a)1.
1. Name and address of the pharmacy or inpatient health care facility where the system is being used.
Phar 7.09(5)(a)4.
4. Written quality assurance procedures to determine continued appropriate use of the system.
Phar 7.09(5)(a)5.
5. Except as required pursuant to
par. (b), written policies and procedures for system operation, safety, security, accuracy, access and malfunction.
Phar 7.09(5)(b)
(b) All written policies and procedures shall be maintained in the pharmacy responsible for the automated dispensing system.
Phar 7.09(5)(c)
(c) An automated dispensing system shall have adequate security systems and procedures, evidenced by written policies and procedures to prevent unauthorized access to maintain patient confidentiality and to comply with federal and state laws.
Phar 7.09(5)(d)
(d) Records and data kept by the automated dispensing system shall meet the following requirements:
Phar 7.09(5)(d)1.
1. All events involving the contents of the automated dispensing systems must be recorded electronically.
Phar 7.09(5)(d)2.
2. Records shall be maintained by the pharmacy and be available to the board. Records shall include:
Phar 7.09(5)(d)2.f.
f. Such additional information as the managing pharmacist may deem necessary.
Phar 7.09(5)(e)
(e) The stocking of all medications in the automated dispensing system shall be accomplished by qualified personnel under no less than the general supervision of a licensed pharmacist; except that when an automated dispensing system is located within a pharmacy the supervision must be direct.
Phar 7.09(5)(f)
(f) A record of medications stocked into an automated dispensing system shall be maintained for 5 years and shall include identification of the person stocking and pharmacist checking for accuracy.
Phar 7.09(5)(g)
(g) All containers of medications stored in the automated dispensing system shall be packaged and labeled in accordance with state and federal law.
Phar 7.09(5)(h)
(h) All aspects of handling controlled substances shall meet the requirements of all state and federal law.
Phar 7.09(5)(i)
(i) The automated dispensing system shall provide a mechanism for securing and accounting for medications removed from and subsequently returned to the automated dispensing system, in accordance with state and federal law.
Phar 7.09(5)(j)
(j) The automated dispensing system shall provide a mechanism for securing and accounting for medication returned to the system and accounting for wasted medications in accordance with state and federal law.
Phar 7.09 History
History: Cr.
Register, October, 2000, No. 538, eff. 11-1-00.
Phar 7.095
Phar 7.095
Operation of remote dispensing sites. Phar 7.095(1)(a)
(a) "Health care facility" means a facility, as defined in s.
647.01 (4), Stats., or any hospital, nursing home, community-based residential facility, county home, county infirmary, county hospital, county mental health center or other place licensed or approved by the department of health services under s.
49.70,
49.71,
49.72,
50.02,
50.03,
50.35,
51.08 or
51.09, Stats., or a facility under s.
45.50,
51.05,
51.06,
233.40,
233.41,
233.42 or
252.10, Stats.
Phar 7.095(1)(b)
(b) "Managing pharmacist" means a pharmacist designated by the pharmacy owner to have responsibility for and direct control of pharmaceutical operations in a pharmacy.
Phar 7.095(1)(c)
(c) "Practitioner" means a person licensed in this state to prescribe and administer drugs or licensed in another state and recognized by this state as a person authorized to prescribe and administer drugs.
Phar 7.095(1)(d)
(d) "Remote dispensing site" means a dispensing site that is not licensed as a pharmacy. Remote does not mean geographical distance or location.
Phar 7.095(1)(e)
(e) "Supervising pharmacy" means a licensed pharmacy that oversees the operations and administration of all aspects of the remote dispensing site.
Phar 7.095(2)
(2) Licensing requirements and use of titles relating to the operation of remote dispensing sites. Phar 7.095(2)(a)(a) A remote dispensing site shall not be licensed as a pharmacy.
Phar 7.095(2)(b)
(b) No person may use or display the title "pharmacy," "drugstore," "apothecary," or any other title, symbol or insignia having the same or similar meanings in connection with a remote dispensing site.
Phar 7.095(3)
(3) Location of remote dispensing sites. A pharmacist may dispense at the following locations:
Phar 7.095(3)(d)
(d) A juvenile correctional facility under s.
938.02 (10p), Stats., juvenile detention facility under s.
938.02 (10r), Stats., residential care center for children and youth under s.
938.02 (15d), Stats., secured residential care center for children and youth under s.
938.02 (15g), Stats., type 1 juvenile correctional facility under s.
938.02 (19), Stats., type 2 residential care center for children and youth under s.
938.02 (19r), Stats., or type 2 juvenile correctional facility under s.
938.02 (20), Stats.
Phar 7.095(4)
(4) Requirements for the operation of remote dispensing sites. Phar 7.095(4)(a)(a) A remote dispensing site shall display a sign, easily viewable by customers, that states all of the following:
Phar 7.095(4)(a)2.
2. This store is a remote dispensing site being supervised by a pharmacist located at all of the following:
Phar 7.095(4)(a)3.
3. The pharmacist is required to talk to you each time you pick up a prescription.
Phar 7.095(4)(b)
(b) A remote dispensing site shall not open for operation if the supervising pharmacy is closed.
Phar 7.095(4)(c)
(c) A remote dispensing site shall not dispense a prescribed drug or device in the absence of the ability of a patient to communicate with the pharmacist.
Phar 7.095(4)(d)
(d) When closed, a remote dispensing site shall have a centrally monitored alarm. For all after hour entries, the personnel entering the site shall record their name, and the date, time and purpose for entering the site in a log. All logs shall be retained for 2 years.
Phar 7.095(4)(e)
(e) A remote dispensing site shall submit written notification to the board 30 days prior to operating the remote dispensing site.
Phar 7.095(5)
(5) Dispensing requirements. A remote dispensing site shall meet all of the following:
Phar 7.095(5)(a)
(a) Comply with the requirements under
s. Phar 7.01 and visually inspect prescription orders, labels and dispensed product.
Phar 7.095(5)(b)
(b) Comply with the labeling requirements under
s. Phar 7.12 (2) (g). The prescription label shall contain the name and address of the supervising pharmacy as the licensed facility from which the prescribed drug or device was dispensed.
Phar 7.095(5)(c)
(c) Comply with federal law if a remote dispensing site dispenses controlled substances.
Phar 7.095(6)(a)(a) The managing pharmacist of a remote dispensing site shall, in accordance with
s. Phar 7.09, do all of the following:
Phar 7.095(6)(a)1.
1. Have written policies and procedures for system operation, safety, security, accuracy and access.
Phar 7.095(6)(a)2.
2. Implement an on-going quality assurance program that monitors performance that includes the number of prescriptions dispensed per month, number of medication errors documented, loss or diversion of inventory, and documentation of remedial training to prevent future errors.
Phar 7.095(6)(a)3.
3. Visit the remote dispensing site at least monthly to conduct controlled substance inventory, to ensure written policies and procedures are being followed, and to ensure that remote dispensing site personnel comply with all federal and state laws regulating the practice of pharmacy.
Phar 7.095(6)(a)4.
4. Retain documentation of the monthly inspection visits at the remote dispensing site for 2 years.
Phar 7.095(6)(b)
(b) The managing pharmacist at the supervising pharmacy is responsible for all remote dispensing sites connected to the supervising pharmacy.
Phar 7.095(7)
(7) Requirements for pharmacy technicians and interns. Pharmacy technicians and interns employed at a remote dispensing site shall satisfy all of the following requirements:
Phar 7.095(7)(c)
(c) Have completed 1500 hours of work as a technician within the 3 years prior to the date of employment at the remote dispensing site or completed a training program approved by the board.
Phar 7.095 History
History: CR 09-099: cr.
Register March 2010 No. 651, eff. 4-1-10.
Phar 7.10
Phar 7.10
Administration of drug products and devices other than vaccines. A pharmacist may administer a drug product, as defined in s.
450.01 (11), Stats., or device, as defined in s.
450.01 (6), Stats., in the course of teaching a patient self-administration techniques except a pharmacist may not administer by injection a prescribed drug product or device unless he or she satisfies each of the following:
Phar 7.10(1)
(1) The pharmacist has successfully completed 12 hours in a course of study and training, approved by the American council on pharmaceutical education or the board, in injection techniques, emergency procedures and record keeping.
Phar 7.10(2)
(2) The pharmacist has in effect liability insurance against loss, expense and liability resulting from errors, omissions or neglect in the administration by injection of prescribed drug products or devices in an amount that is not less than $1,000,000 for each occurrence and $2,000,000 for all occurrences in any one policy year. The pharmacist shall maintain proof that he or she satisfies this requirement and, upon request, shall provide copies of such proof to the department or board.
Phar 7.10(3)
(3) The pharmacist has written procedures regarding the administration by injection of a prescribed drug product or device in the course of teaching self-administration techniques to a patient.
Phar 7.10 Note
Note: To administer a vaccine a pharmacist must meet the requirements in s.
450.035, Stats.
Phar 7.10 History
History: Cr.
Register, December, 1999, No. 528, eff. 1-1-00.
Phar 7.12(1)(a)
(a) "Central fill pharmacy" means a pharmacy licensed in this state acting as an agent of an originating pharmacy to fill or refill a prescription.
Phar 7.12(1)(b)
(b) "Originating pharmacy" means a pharmacy licensed in this state that uses a central fill pharmacy to fill or refill a prescription order.
Phar 7.12(2)
(2) A central fill pharmacy and originating pharmacy may process a request for the filling or refilling of a prescription order received by an originating pharmacy only pursuant to the following requirements:
Phar 7.12(2)(a)
(a) The central fill pharmacy either has the same owner as the originating pharmacy or has a written contract with the originating pharmacy outlining the services to be provided and the responsibilities of each pharmacy in fulfilling the terms of the contract in compliance with federal and state law.
Phar 7.12(2)(b)
(b) The central fill pharmacy shall maintain a record of all originating pharmacies, including name, address and DEA number, for which it processes a request for the filling or refilling of a prescription order received by the originating pharmacy. The record shall be made available upon request for inspection by the board or its agent.
