:   (CLEARINGHOUSE RULE 19-145)
An order of the Pharmacy Examining Board to repeal and recreate ch. Phar 7 relating to the practice of pharmacy.
Analysis prepared by the Department of Safety and Professional Services.
Statutes interpreted: ss. 450.033, 450.035, 450.062, 450.09, 450.11, 450.12, Stats.
Statutory authority: ss. 15.08 (5) (b), 450.02 (2), and 450.02 (3) (a) to (e), and 961.31, Stats.
Explanation of agency authority:
The Board shall promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains, and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession. [s. 15.08 (5) (b), Stats.]
The board shall adopt rules defining the active practice of pharmacy. The rules shall apply to all applicants for licensure under s. 450.05. [s. 450.02, Stats.]
The board may promulgate rules:
(a) Relating to the manufacture of drugs and the distribution and dispensing of prescription drugs.
(b) Establishing security standards for pharmacies.
(c) Relating to the manufacture, distribution and dispensing of hypodermic syringes, needles and other objects used, intended for use or designed for use in injecting a drug.
(d) Necessary for the administration and enforcement of this chapter and ch. 961.
(e) Establishing minimum standards for the practice of pharmacy.
[ss. 450.02 (3) (a) to (e), Stats.]
The pharmacy examining board may promulgate rules relating to the manufacture, distribution and dispensing of controlled substances within this state. [s. 961.31, Stats.]
Related statute or rule: Phar 6 and 8
Plain language analysis:
This rule repeals and recreates the chapter delineating the practice of pharmacy.
A prescription is required to have the date of issue, name and address of the prescriber (and if delegated that person’s name), directions for use, the drug’s name, strength, and quantity, whether there are any refills authorized, name and address of the patient (unless omission is required by statute) and the prescriber’s signature. A standing order is required to have all the same elements as a prescription with the exception of prescriber’s signature and indicate that it is pursuant to a standing order. A pharmacist may dispense pursuant to an electronic prescription, if the prescription is sent to the patient’s choice of pharmacy, contains the elements of a prescription and may be signed with the prescriber’s electronic signature. Verbal prescriptions may be received and reduced to writing on paper or in a computer system. Any alterations to a prescription which changes the prescriber’s original intent must be documented including the pharmacist who made the alteration and the prescriber who authorized the change.
A drug utilization review must be completed prior to dispensing a prescription drug. It includes checking the prescription for the following: known allergies, rational therapy, contraindications, reasonable dose, duration of use and route of administration, reasonable directions for use, potential or actual adverse drug reactions, drug interactions with food, beverages, other drugs or medical conditions, therapeutic duplication, reasonable utilization and optimum therapeutic outcomes and potential abuse or misuse. If there is a concern with any of these items, the pharmacist will take steps to mitigate or resolve the matter.
A prescription can be transferred either orally between two pharmacists or between two pharmacies by fax machine or electronically. New or refill prescriptions for non-controlled substances can be transferred by indicating the prescription is void at the original pharmacy and indicating the prescription is a transfer at the receiving pharmacy. Unless a real time shared computer is used between the pharmacies, for non-controlled substances the receiving pharmacy will record the name and address of the patient, name and address of the prescribing practitioner, name, strength, form and quantity of the drug product or device, date of issue of the original prescription, the original prescription order number, original number of refills authorized, dates of last fills, number of valid refills or quantity remaining, original pharmacy name and address and the names of the transferring and receiving pharmacists. Refill prescriptions for controlled substances can be transferred by communication directly between 2 licensed pharmacists utilizing the same procedures as a non-controlled with the addition of recording the drug enforcement administration (DEA) registration numbers of the originating pharmacy and prescriber, and dates and locations of previous fills..
All prescription drugs and devices shall have a label. The label will identify the patient, symptom or purpose (if indicated on prescription), name and strength of drug, date the drug should not be used after, the name, address and telephone number of the pharmacy, prescriber name, date prescription filled, prescription number, quantity, and number of refills or quantity remaining, and directions for use. A label may include the symptom or purpose if requested by the patient, both generic and brand names unless the prescriber requests the brand name be omitted, written or graphic product descriptions and any other cautions or provisions. A label is not required on complimentary drug or device samples dispensed in original packaging by a prescriber.
A pharmacist can repackage non-sterile drugs into different containers for stocking purposes. When repackaging drugs into other containers, the pharmacist must ensure the process is done under conditions which will not compromise the integrity of the drug, select containers which mitigate adulteration from light, temperature or humidity, and label the new container(s) with drug name, strength and form, beyond use date and a set of identifiers (pharmacy control or national drug code (NDC) and manufacturer lot number, or manufacturer or distributor name, and manufacturer lot number. Records must include the drug name, strength and form, the quantity in each container and number of containers the drug was repackaged into, the NDC number (or if not available manufacturer or distributor), manufacturer lot number, the original container’s expiration date and the beyond use date for the new containers, the name of the pharmacist or delegate that repackaged the drug, the name of the pharmacist that verified the accuracy of the repackaging and the date the repackaging was done.
All prescription drugs and devices must have a final check prior to dispensing. A final check includes checking that label requirements are met, it is the correct drug product or device, and a drug utilization review was completed. The check can be done by one or multiple pharmacists, with the prescription record reflecting which pharmacist was responsible for each part of the final check. If the label and product verification was done by automated technology or delegate check delegate, the prescription record will reflect the name of the delegate.
A pharmacist must consult the patient or patient’s agent for every new prescription which has not been dispensed previously to the patient, any change in the patient’s therapy, upon request of a patient or patient’s agent and whenever it is in the pharmacist’s professional judgement a consultation should occur. Consultation is not required when the drug or device is administered by or in the presence of an individual with a scope of practice that includes administration of a drug or device or the individual’s delegate or a patient or patient’s agent refuses consultation. Patient consultation includes, based upon the pharmacist’s professional judgment, the name and description of the drug, form, dose, route of administration and duration for drug therapy, intended use of the drug and expected action, directions and precautions, common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, how to avoid and action if they occur, techniques for self-monitoring drug therapy, proper storage and disposal and action to be taken in the event of a missed dose. The consultation is required to be verbal when the pharmacist deems it is in the patient’s best interest to do so. In addition, when a consultation is required, the pharmacist shall provide a written patient drug education monograph. Every pharmacy shall post a sign stating a patient’s right to consultation and information on how to file a complaint to the board and board approved information stating patient’s rights shall accompany all delivered prescriptions by common carrier or delivery service or picked up at a drive through window.
Delivery of prescription drugs by common carrier or delivery services shall ensure the delivery method is appropriate to prevent drug adulteration. The patient must be provided with a method to report any irregularities in the delivery including timeliness, condition of the drug and failure to receive the correct drug or device. Any drug compromised by delivery or lost must be replaced at no additional cost to the patient. If the timing of the replacement will lead to interruption in therapy, steps must be taken by a pharmacist to mitigate patient harm.
A pharmacy must have a system for identifying any drugs or devices subject to a recall and to take appropriate action as required in a recall notice. A drug or device can’t be dispensed after its expiration or beyond use date. All outdated drugs or devices must be removed from dispensing stock and quarantined until properly disposed.
Links to Admin. Code and Statutes in this Register are to current versions, which may not be the version that was referred to in the original published document.