PHARMACY EXAMINING BOARD
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IN THE MATTER OF RULE-MAKING : ORDER OF THE
PROCEEDINGS BEFORE THE : PHARMACY EXAMINING BOARD
PHARMACY EXAMINING BOARD : ADOPTING RULES
: (CLEARINGHOUSE RULE 19-145)
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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.
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.
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. The DEA does not permit the return of controlled substances to a pharmacy under any circumstances. Only returned health items that are prepackaged for consumer use without a prescription 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. Pharmacy records are to be kept for a minimum of five years. A computerized system may be used if it is capable of producing a printout of the data contained in it and there is another procedure for documentation f dispensing and refills are authorized during periods of time the computer is not working. Prescription records are to be kept for 5 years after the date of the last refill. A paper prescription for non-controlled substances can be scanned and stored electronically (and at that point becomes an electronic prescription). A medication profile record system must contain the patient’s name, address, date of birth, name of drug product or device dispensed, strength and form of the drug product or device dispensed, quantity dispensed and remaining, number of refills prescribed, directions for use, prescription order number, original date of issue, date of dispensing and the prescriber’s name. A pharmacist will be responsible for attempting to ascertain and record any patient allergies, adverse drug reactions, drug idiosyncrasies, and any chronic conditions which may affect drug therapy. Medication profile records are to be kept for 5 years following the date of the last dispensing.
Any delegation by a physician to a pharmacist shall be documented by the pharmacist. The delegated act may not begin until it is documented. The documentation shall be maintained for a minimum of 5 years after the last delegated act under the delegation.
A pharmacist may not administer by injection a prescribed drug product or device (other than vaccines) unless the pharmacist has completed a course of study and training in administration techniques. A person who has successfully completed their second year and is enrolled in a school of pharmacy or a pharmacist licensed in another state who has applied for a Wisconsin pharmacist license may not administer a drug product or device (other than vaccines) unless they successfully complete a course of study and training in administration technique and administers the drug product or device only under the direct supervision of a pharmacist who has successfully completed the course of study.
The course of study must be from a course provider approved by the Accreditation Council for Pharmacy Education or the Board. The Board will evaluate programs using criteria substantially equivalent to the criteria used by the Accreditation Council or Pharmacy Education. After the pharmacist administers a prescribed drug product or device (other than vaccines), the pharmacist or the pharmacist’s agent shall notify the prescribing practitioner or enter the information in a patient record system the pharmacist shares with the prescribing practitioner.
Delegate-check-delegate allows a supervising pharmacist to delegate the product verification of a product prepared by another person delegated by the pharmacist.
In order for a person to be delegated product verification, the individual must meet all of the following: be 18 years of age; completed an accredited technician training program or has a minimum of 500 hours of experience in product selection labeling and packaging; completed a didactic and practical training curriculum; and completed a validation process.
The didactic and practical training curriculum must include elements of a package label; medication and pharmacy abbreviations needed to match ordered medication with dispensed medication; common dispensing medication errors and concepts; eligible medications; policies and procedures on reporting of medication errors; overview of the pharmacy’s medication use process and a practical training designed to assess the competency of the individual. The validation process requires a check of 500 product verifications over at least 5 days with an accuracy rate of at least 99.8%. A product is eligible in institutional pharmacies if the medication is contained in a final package from a manufacturer or if the licensed pharmacist has ensured that the repackaging process of stock is labeled with the correct drug name, dose, strength, form, control or lot number and beyond use date. In an institutional pharmacy the medication is required to be administered by a health care provider or a person authorized to administer drugs at the institution. Product verifications can be done by delegates in community pharmacies if the medication is contained in an original package from a manufacturer or if the licensed pharmacist has ensured that the repackaging process of stock is labeled with the correct drug name, dose, strength, form, control or lot number and beyond use date. In a community pharmacy the medication is required to have a method for a patient to be able to check the accuracy of the medication. Each pharmacy is required to maintain policies, procedures, and training materials. The following records are required to be kept: all validation records, documentation of supervising and managing pharmacist responsibilities and dates of supervision responsibilities.
A pharmacy may use a central shared services pharmacy acting as its agent. The central shared services pharmacy must be owned by the same owner as the originating pharmacy or have a written contact with the originating pharmacy outlining the services to be provided and the responsibilities of each pharmacy. The central shared services pharmacy must keep a record of all originating pharmacies it serves including name, address and DEA number. The originating and central shared services pharmacies shall maintain a written protocol outlining each pharmacy’s assumption of responsibility for compliance with state and federal law. If the central shared services pharmacy and originating pharmacy share a computer system, the central shared services pharmacy may perform drug utilization review. The prescription label will have the name and address of either pharmacy. The date the prescription was dispensed will be the date the pharmacy filled the prescription order.
A prescription can be delivered to a secure delivery system. The system must be designed in a manner which only the patient or patient’s agent is able to open the door or locker containing only the patient’s prescription and designed in a manner which does not disclose protected health information. It also must maintain appropriate environmental controls to prevent drug adulteration. Using a delivery system does not create an exemption to the controlled substances photo identification requirement. The dispensing pharmacy is to maintain a log of all prescriptions delivered to the delivery system and inventory it at least weekly so that unclaimed prescriptions can be reviewed by a pharmacist. The managing pharmacist shall develop written policies and procedures for stocking, access, and mitigation of diversion or theft.
Automated direct-to-patient dispensing systems (more generally described as vending machines) may be used in health care facilities, office or clinic of a practitioner, a county jail, rehabilitation facility, state prison, or county house of correction or a juvenile correctional facility, juvenile detention facility, residential care center, and a secured residential care center for children and youth. The automated direct-to-patient dispensing system may operate for purposes of practitioner dispensing. The supervising practitioner is responsible for: ensuring the stocking, inventory, and monitoring is limited to the supervising practitioner or delegate; labeling of the prescriptions in compliance with Phar 7.05; records of all prescription fills and dispenses are maintained for 5 years; and all monitored prescription drugs dispensed are reported to the prescription drug monitoring program.
Remote dispensing may be done at health care facilities, office or clinic of a practitioner, a county jail, rehabilitation facility, state prison, or county house of correction or a juvenile correctional facility, juvenile detention facility, residential care center, and a secured residential care center for children and youth. The managing pharmacist will designate a supervising pharmacist for the remote dispensing. A sign shall be posted indicating prescriptions may be filled at the location and the supervising pharmacy. Remote dispensing can’t occur if the supervising pharmacy is closed. No prescribed drug or device may be dispensed in the absence of a patient and pharmacist’s delegate to communicate with a pharmacist. The prescription label shall contain the name and address of the supervising pharmacy. The managing or supervising pharmacist shall have written policies and procedures, implement on-going quality assurance program, visit the remote dispensing location at least monthly to confirm delivery status of all drugs and to ensure compliance with federal and state laws and retain documentation of the visits for a minimum of 5 years. A pharmacist delegate who is remote dispensing must be 18 years of age or older, a high school graduate or equivalent and competed 1500 hours of work as a pharmacist delegate within 3 years prior to remote dispensing or completed an accredited technician training program.
Institutional pharmacies are pharmacies serving institutional facilities. Chart orders shall contain patient’s name, patient’s medical record number or date of birth, date of issuance, name, strength and form of the drug product or device prescribed, directions for use, practitioner’s signature, and if prepared by a delegate of the practitioner the delegate’s signature and name of the practitioner. All drug products and devices dispensed for administration by a health care provider at the institutional facility shall have a label that includes the drug name, strength and form, beyond use date or expiration date, and any special storage conditions. The managing pharmacist shall make arrangements for access of drugs by health care staff when a pharmacist is not available to do the dispensing. In the absence of a pharmacist, drugs shall be stored in a manner that only authorized personnel may obtain access and is secure enough to deny access to unauthorized persons. Policies and procedures must be in place to mitigate and prevent theft and diversion. A health item can be returned to the institutional pharmacy if it has not left control of the health care facility staff authorized to have access to prescription drug products. A returned health item may be dispensed at the institutional facility if the health item was never in the possession and control of the patient, it is in a tamper-evident package, it is in the original container and the pharmacist determines the contents are not adulterated or misbranded.
Automated technology can be utilized for the product verification of a prescription if the machine is located within the pharmacy, utilizes barcodes or other machine-readable technology for product verification and the automated technology is validated for accuracy. Product verifications can be done by automated technology if it is contained in a final package from a manufacturer or if a licensed pharmacist has ensured that the packaging process results in a final package that is labeled with the correct drug name, strength, form, control or lot number and beyond use date.
The medication is required to be administered by a person authorized to administer drugs within the institution. Each pharmacy is required to maintain policies, procedures, and training materials. The following records are required to be kept: all validation records, names of supervising pharmacist, managing and supervising pharmacist responsibilities, manufacturer’s recommended maintenance and quality assurance measures, dates of all software upgrades, and documentation of all service performed outside of the manufacturer’s standard maintenance recommendations.
A person practicing pharmacy who has completed their second year of pharmacy school or is a pharmacist from another state applying for license in Wisconsin, can perform duties under direct supervision.
An unlicensed person performing tasks delegated to the person by a pharmacist is working under general supervision. A pharmacist must be available to the unlicensed person for consultation either in person or contact by telecommunication means. An unlicensed person may not provide the final verification for accuracy, validity, or completeness of a filled prescription or order unless the person is validated for delegate-check-delegate. An unlicensed person may not complete the drug utilization review, administer any prescribed drug products, devices or vaccines or provide patient specific counseling or consultation (general education is allowed). The managing pharmacist shall provide training to or verify competency of an unlicensed person in performing a delegated act. The managing pharmacist shall determine what acts may be delegated in the pharmacy. The managing pharmacist has a responsibility to notify all pharmacists practicing in the pharmacy of what acts may be delegated to specific unlicensed persons. A pharmacist may delegate to an unlicensed person any delegated act approved by the managing pharmacist.
