Phar 7.08 Phar 7.08 Prescription orders transmitted electronically.
Phar 7.08(1)(1)Except as provided in s. 89.068 (1) (c) 4., Stats., and as otherwise prohibited by law, prescription orders may be accepted and dispensed if they have been transmitted electronically from a practitioner or his or her designated agent to a pharmacy via computer modem or other similar electronic device. Prescription orders transmitted by facsimile machine are not considered electronic prescription orders; but rather, written prescription orders.
Phar 7.08(2) (2)A pharmacist may dispense a prescription pursuant to a prescription order transmitted electronically, if the pharmacist assures the prescription order does all of the following:
Phar 7.08(2)(a) (a) Was sent only to the pharmacy of the patient's choice and only at the option of the patient, with no intervening person or third party having access to the prescription order other than to forward it to the pharmacy.
Phar 7.08(2)(b) (b) Identifies the individual sender's name and telephone number for oral confirmation, the time and date of transmission, and the pharmacy intended to receive the transmission.
Phar 7.08(2)(c) (c) Is designated “electronically transmitted prescription", or with similar words or abbreviations to that effect.
Phar 7.08(2)(d) (d) Contains all other information that is required in a prescription order.
Phar 7.08(3) (3)The prescribing practitioner's electronic signature, or other secure method of validation shall be provided with a prescription order electronically transmitted via computer modem or other similar electronic device.
Phar 7.08(4) (4)Any visual or electronic document received in connection with an electronically transmitted prescription order shall be accessible only within the professional service area of the pharmacy to protect patient confidentiality and assure security.
Phar 7.08(5) (5)A pharmacist who receives a prescription order electronically shall ensure the security, integrity and confidentiality of the prescription order and any information contained in the order. To maintain the confidentiality of patient records, the electronic system shall have adequate security and system safeguards designed to prevent and detect unauthorized access, modification, or manipulation of patient records. Once the prescription has been dispensed, any alterations in prescription order drug data shall be documented including the identification of the pharmacist responsible for the alteration.
Phar 7.08(6) (6)Access to the electronic mail system for the receipt of prescription orders electronically may only be acquired by use of a password or passwords, known only to individuals authorized to access the system.
Phar 7.08(7) (7)A pharmacist may not use any electronic device to circumvent his or her responsibilities with regard to documenting, authenticating and verifying prescription orders or in order to circumvent other pharmacy laws.
Phar 7.08 History History: Cr. Register, November, 1999, No. 527, eff. 12-1-99; correction in (1) made under s. 13.92 (4) (b) 7., Stats., Register February 2017 No. 734.
Phar 7.09 Phar 7.09 Automated dispensing systems.
Phar 7.09(1)(1)In this section:
Phar 7.09(1)(a) (a) “Automated dispensing system" means a mechanical system that perform operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing or distribution of medications, and which collects, controls, and maintains all transaction information.
Phar 7.09(1)(b) (b) “Inpatient health care facility" means any hospital, nursing home, county home, county mental hospital, or tuberculosis sanitorium, but does not include community-based residential facilities.
Phar 7.09(2) (2)An automated dispensing system may be used in a community pharmacy, as provided in this section.
Phar 7.09(3) (3)An automated dispensing system may be used as provided in this section by an institutional pharmacy serving an inpatient health care facility, that has an established program of receiving prescription orders, and dispensing and returning prescription medications consistent with accepted inpatient institutional drug distribution systems. An automated dispensing system used by an institutional pharmacy shall only be located in that institutional pharmacy or within the inpatient health care facility.
Phar 7.09(4) (4)The managing pharmacist of a community pharmacy or an institutional pharmacy is responsible for all of the following:
Phar 7.09(4)(a) (a) Assuring that the automated dispensing system is in good working order and accurately dispenses the correct strength, dosage form, and quantity of the drug prescribed and complying with the recordkeeping and security safeguards pursuant to sub. (5).
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)1. 1. Name and address of the pharmacy.
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)(c)3. 3. Identification of the managing pharmacist.
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)2. 2. The system manufacturer's name, model and serial number.
Phar 7.09(5)(a)3. 3. Description of how the system is 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.a. a. The time and location of the system accessed.
Phar 7.09(5)(d)2.b. b. Identification of the individual accessing the system.
Phar 7.09(5)(d)2.c. c. Type of transaction.
Phar 7.09(5)(d)2.d. d. Name, strength, dosage form and quantity of the drug accessed.
Phar 7.09(5)(d)2.e. e. Name of the patient for whom the drug was ordered.
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)(1)Definitions. In this section:
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)(a) (a) A health care facility or a facility identified under s. 980.065, Stats.
Phar 7.095(3)(b) (b) The office or clinic of a practitioner.
Phar 7.095(3)(c) (c) A county jail, rehabilitation facility under s. 59.53 (8), Stats., state prison under s. 302.01, Stats., or county house of correction under s. 303.16 (1), Stats.
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)1. 1. Prescriptions may be filled at this location.
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)2.a. a. Name of store.
Phar 7.095(4)(a)2.b. b. Address of store.
Phar 7.095(4)(a)2.c. c. Telephone number of store.
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) (6)Responsibilities of managing pharmacists.
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.
Loading...
Loading...
Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.