Immediate administration of the controlled substance is necessary for proper treatment of the patient.
No appropriate alternative treatment is available, including the administration of a drug which is not a schedule II controlled substance.
It is not reasonably possible for the prescribing practitioner to provide a written prescription order to be presented to the pharmacist prior to dispensing.
In an emergency a pharmacist may dispense a controlled substance listed in schedule II upon receiving oral authorization of a practitioner if:
The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period.
The prescription order is immediately reduced to writing by the pharmacist and contains all information required in s. Phar 8.05
, except for the signature of the practitioner.
If the practitioner is not known to the pharmacist, the pharmacist shall make a reasonable effort to determine that the oral authorization came from an authorized practitioner, which may include a call back to the prescribing practitioner using good faith efforts to insure the practitioner's identity.
Within 7 days after authorizing an emergency oral prescription order, the practitioner shall cause a written or electronic order for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of s. Phar 8.05
, the order shall contain on its face “authorization for emergency dispensing" and the date of the oral order. The written or electronic order may be delivered to the pharmacist in person or by mail or electronically, but if delivered by mail it shall be postmarked within the 7 day period. Upon receipt, the dispensing pharmacist shall attach this prescription order to the oral emergency order reduced to writing under sub. (2) (b)
. The pharmacist shall notify the board or department of safety and professional services if the practitioner fails to deliver the written or electronic order. Failure of the pharmacist to provide notification shall void the authority conferred by this section to dispense without a written or electronic order of a practitioner.
Phar 8.09 History
Cr. Register, January, 1983, No. 325
, eff. 2-1-83; am. Register, August, 1991, No. 428
, eff. 9-1-91; am. (4), Register, December, 1998, No. 516
, eff. 1-1-99; am. (1) (intro.), (2) (intro.), (3) and (4), Register, November, 1999, No. 527
, eff. 12-1-99; correction in (4) made under s. 13.92 (4) (b) 6.
, Stats., Register February 2012 No. 674
; CR 13-075
: am. (1) (intro.), (2) (intro.), (3), (4) Register August 2014 No. 704
, eff. 9-1-14.
Phar 8.10 Disclosure of suspicious orders of controlled substances.
Manufacturers and distributors of controlled substances shall disclose suspicious orders of controlled substances. Suspicious orders include, without limitation because of enumeration, orders of unusual size, orders deviating substantially from a normal pattern and orders of unusual frequency. The licensee shall notify the regional office of the DEA and the board of all suspicious orders.
Phar 8.10 History
Cr. Register, August, 1991, No. 428
, eff. 9-1-91.
Phar 8.11 Controlled substances in emergency kits for long term care facilities.
Long term care facilities which are not registered with the DEA shall meet all of the following requirements regarding emergency kits containing controlled substances:
The source of supply must be a DEA registered hospital, pharmacy or practitioner.
The pharmaceutical services committee of the facility shall establish security safeguards for each emergency kit stored in the LTCF which shall include the designation of individuals who may have access to the emergency kits and a specific limitation of the type and quantity of controlled substances permitted to be placed in each emergency kit.
A pharmacist shall be responsible for proper control and accountability for such emergency kits within the LTCF which includes the requirement that the LTCF and the providing DEA registered hospital, pharmacy or practitioner maintain complete and accurate records of the controlled substances placed in the emergency kits, the disposition of those controlled substances, plus the requirement to take at least monthly physical inventories.
The pharmaceutical services committee will establish the emergency medical conditions under which the controlled substances may be administered to patients in the LTCF which shall include the requirement that medication be administered by authorized personnel only as expressly authorized by an individual DEA registered practitioner and in compliance with all applicable federal and state laws.
Noncompliance with this rule may result in revocation, denial or suspension of the privilege of having or placing emergency kits, containing controlled substances, in LTCF.
Phar 8.11 History
Cr. Register, August, 1991, No. 428
, eff. 9-1-91.
Phar 8.12 Prescription orders transmitted by facsimile machine. Phar 8.12(1)(1)
Prescription drugs other than schedule II controlled substances.
A pharmacist may dispense a prescription drug, other than a schedule II controlled substance, pursuant to a prescription order transmitted by a facsimile machine from the practitioner or the practitioner's agent to the dispensing pharmacy if all of the following conditions are met:
The transmitted facsimile prescription order shall contain all of the information required for a valid written prescription order. The order shall also contain the time and date of the transmission, as well as the telephone number and name of the transmitter.
Unless the facsimile paper is non-fading, the facsimile prescription order received shall be duplicated by copy machine or other similar device and the copy must be physically attached to the order received.
(2) Schedule II controlled substances.
A pharmacist may not dispense a schedule II controlled substance pursuant to a prescription order transmitted by a facsimile machine unless all of the conditions stated in sub. (1)
are satisfied, and any of the following conditions are met:
The prescription order is written for a schedule II controlled substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion, and is transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile.
The prescription order is written for a schedule II controlled substance for a patient who resides in a long term care facility, or who meets the eligibility requirements for placement in a long term care facility but elects to reside at home, and is transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile.
The prescription order is written for a schedule II controlled substance for a patient enrolled in a hospice certified by medicare under Title XVIII or licensed by this state, and is transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile.
(3) Prescription orders transmitted by facsimile considered written orders.
For all purposes under chs. 450
, Stats., and the rules of the board, a prescription order transmitted by facsimile machine shall be considered the original written prescription order.
Phar 8.12 History
Cr. Register, December, 1998, No. 516
, eff. 1-1-99; CR 09-098
: am. (2) (b) Register May 2010 No. 653
, eff. 6-1-10.
Phar 8.13 Identification card exception for a health care facility.
In s. 450.11 (1b) (e) 3.
, Stats., “health care facility" means a facility, as defined in s. 647.01 (4)
, Stats.; any hospital, nursing home, community-based residential facility, county home, county infirmary, county hospital, county mental health complex, or other place licensed or approved by the department of health services under s. 49.70
, or 51.09
, Stats.; a facility under s. 45.50
, or 252.10
, Stats.; and a hospice facility under s. 50.90 (1) (c)
Phar 8.13 History
History: CR 16-018: cr. Register September 2016 No. 729, eff. 10-1-16; correction made under s. 35.17, Stats., Register September 2016 No. 729.