STATE OF WISCONSIN
PHARMACY EXAMINING BOARD
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IN THE MATTER OF RULE-MAKING : PROPOSED ORDER OF THE
PROCEEDINGS BEFORE THE : PHARMACY EXAMINING BOARD
PHARMACY EXAMINING BOARD : ADOPTING RULES
: (CLEARINGHOUSE RULE )
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PROPOSED ORDER
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.
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ANALYSIS
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.
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 it is written, name and address of the prescriber (and if delegated that person’s name), the drug’s name, strength, formulation and quantity, whether there are any refills authorized, name of the patient 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 for abuse or misuse. If there is a concern with any of these items, the pharmacist will take steps to 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, 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 the original prescription, the original prescription order number, original number of refills authorized, dates of previous dispensing, 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 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.
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, number of refills or quantity remaining, and written or graphic product descriptions. 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, 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 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, pharmacy control or manufacturer lot number, national drug code (NDC) or if NDC is not available, the manufacturer or distributor name, and the beyond use date or expiration date. 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 pharmacist supervising the delegation.
A pharmacist must consult the patient or patient’s agent for every new prescription which has not been dispensed previously to the patient or any change in the patient’s therapy. Patient consultation includes 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, special 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. A pharmacist may omit or vary the content of the consultation if it is in the best interest of the patient. The information must be transmitted orally unless it is the pharmacist’s judgment it is not in the best interest of the patient. In addition, the information contained in the consultation must be given to the patient or patient’s agent in writing and the patient or patient’s agent advised by what method the pharmacist may be contacted for consultation. Consultation is available upon patient request and a pharmacist shall use professional judgment in determining whether to do a consultation on a prescription refill. A consultation is not required when a health care provider is administering the medication or if a patient or patient’s agent refuses consultation. Every pharmacy shall post a sign stating a patient’s right to consultation and information on how to file a complaint for failure to consult and a copy of the sign shall accompany all delivered prescriptions by common carrier or delivery service.
Delivery of prescription drugs by common carrier or delivery services shall ensure environmental controls are in place to prevent drug adulteration. The delivery method provides for verification of receipt of all controlled substances. 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 shall be replaced at no additional cost to the patient by next day delivery or the pharmacist will contact the prescriber to arrange for a 7 day supply of the prescription drug product to be dispensed by a pharmacy of the patient’s choice.
A pharmacy shall get prescription drugs from a drug wholesaler licensed by the board or U.S. Food and Drug Administration or from another licensed pharmacy or practitioner located in the United States. 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.
The only health care items that may be returned to a pharmacy are health care items dispensed in error, defective, adulterated or misbranded, when in the pharmacist’s professional judgment substantial harm could result to the public or patient if they were to remain in the possession of the patient, patient’s family or others, or a health item is prepackaged for consumer use without a prescription when returned in compliance with state or federal laws. Only returned health items that are prepackaged for consumer use may be sold, resold or dispensed. It is not considered a return if the health care item is returned to the pharmacy for purposes of packaging, relabeling and returned to the same patient. This rule does not prohibit participation in a drug repository program in accordance with ch. DHS 148.
