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.
Summary of, and comparison with, existing or proposed federal regulation:
Generally, the practice of pharmacy is under state jurisdiction.
There are federal regulations related to controlled substances and drug supply chain.
21 CFR 1306.25 governs the transfer of controlled substances prescriptions for refill purposes. This proposed rule mirrors the federal requirements. Title II of the Drug Quality and Security Act requires all health care providers who dispense or administer prescription drugs to patients to purchase their prescription drug products only from authorized trading partners licensed by or registered with the state or federal government.
Comparison with rules in adjacent states:
Illinois: Illinois has elements required to be on a prescription and labels. Transfers for the purpose of original fill or refill shall include name, address and original prescription number, and all prescription data. A prescription for a Schedule III-IV controlled substance must follow federal law. A drug being removed from the original manufacturer container and placed in a dispensing container for other than immediate dispensing to a patient must contain a label indicating the name and strength of the drug, manufacturer or distributor name, beyond use date, and lot number. Illinois requires consultation for a prescription to a new patient, new medication to existing patient and medication that changes dose, strength, route or directions. An offer to consult is required on all other prescriptions. Consult is not required if a patient refuses consult or if a health care provider is administering the drug. There are designated required elements to be included in consultation. If oral counseling is not practicable, then alternative forms of patient information are provided and shall advise the patient that the pharmacist may be contacted for consultation in person at the pharmacy or by toll-free or collect telephone service. Every licensed pharmacy must post a sign with patient’s rights to a consultation and information on how to file a complaint for failure to consult. Pharmacies without a physical location directly serving patients must include a copy of the sign with any dispensed prescriptions. A mail order pharmacy is required to provide a toll-free telephone service available not less than 6 days per week for a minimum of 40 hours per week. Once a drug is removed from the premises by a patient or the patient’s agent, that drug shall not be accepted for return or exchange by a pharmacy or pharmacist. Drugs can be returned for destruction; the wrong medication was dispensed or drug recall. Pharmacy and prescription records are to be maintained for 5 years. Pharmacies providing centralized prescription filling shall share a common electronic file to allow access to sufficient information necessary to fill or refill a prescription order. Appropriate records shall be maintained to identify a responsible pharmacist in the dispensing process and to track the prescription drug order during each step in the process. A delivery system must be secured against a wall or floor, provide a method to identify the patient and deliver the prescription only to that patient or the patient’s agent. The delivery system must have adequate security systems to prevent unauthorized access, maintain patient confidentiality and record the time and date the patient removed the prescription from the delivery system. A remote dispensing site is under the supervision of a pharmacy. All records must be maintained at the home pharmacy. Prescriptions dispensed at the remote site shall be distinguishable from those dispensed from the home pharmacy. A pharmacist at the home pharmacy must verify each prescription before it leaves the remote site. Counseling must be done by a pharmacist via video link and audio link before the drug or device is released. A pharmacist must make monthly inspections of the remote site. There shall be a working computer link, video link and audio link working at all times between the remote site and the home pharmacy unless a pharmacist is present at the remote site. The sign must clearly identify it as a remote dispensing site.
Remote consulting sites can’t have any prescription inventory-only filled prescriptions by the home pharmacy. Institutional labels for administration shall include drug name, strength, beyond use date and reference code to identify source and lot number. An after-hour cabinet shall contain a minimal supply of the most frequently required medication and shall only be used in the absence of a pharmacist. Only personnel specifically authorized by the institution may obtain access and it is sufficiently secure to deny access to unauthorized persons. In an institutional health care facility where a licensed healthcare professional administers the drug, a drug may be returned if the drug is not contaminated, deteriorated or beyond the use date, returns are properly documented and obtaining payment twice for the same drug is prohibited. Illinois does not allow for delegation to unlicensed persons. Illinois certifies technicians.
Iowa: In Iowa, the original prescription shall be retained in the original format. Each prescription shall have specified elements. Dispensing documentation shall include the date of fill; the name, strength, NDC of the drug; and the initials of the pharmacist, pharmacist-intern, or technician in an approved tech-check-tech program. The pharmacy shall ensure that the prescription drug or medication order has been issued for a legitimate medical purpose by a prescriber. The pharmacist shall do a prospective drug use review to promote therapeutic appropriateness and rational drug therapy. If there are any problems, the pharmacist shall take appropriate steps to resolve. When transferring a prescription, both the transferring and receiving pharmacies shall maintain records of the prescription drug order information. Non-controlled substances prescriptions are permissible to be transferred as long as the number of transfers does not exceed the number of authorized refills and the prescription is still valid. Transfer of Schedule III – IV prescriptions are permissible on a one-time basis except as provided by federal law. The prescription label shall include prescription number, name, telephone number and address of the pharmacy, name of the prescriber, date dispensed, directions for use and unless directed by the prescriber, the name, strength and quantity of the drug dispensed. Iowa requires a consultation for new prescriptions and change in drug therapy. Consultation is not required when other licensed health care professionals are authorized to administer drugs or if the patient refuses consultation. There are discretionary elements to the consultation. An offer to counsel shall not fulfill the requirements of the rule. If in the pharmacist’s professional judgment oral counseling is not practicable, the pharmacist may use alternative forms of patient information. “Not practicable” refers to the patient variables and does not include pharmacy variables. Nonresident pharmacies shall ensure that Iowa patients receive appropriate counseling pursuant to the Iowa rule. Prescriptions may be delivered by common carrier or delivery service to the patient at the office or home of the prescriber, at the residence of the patient or caregiver, at the hospital or medical care facility, an outpatient medical care facility or place of employment. Prescriptions may be delivered to the place of employment only if the pharmacy has the patient’s written authorization, the prescription is delivered directly to or received directly from the patient or agent and the pharmacy ensures the security of confidential information. Pharmacies shipping or delivering drugs shall ensure accountability, safe delivery, and compliance with temperature requirements. There shall be a patient record system. Records shall be stored for 2 years. Iowa allows automated technology to conduct the product verification if the system utilizes barcode scanning technology and the product is prestocked and no manipulation of drug or package other than affixing a patient label is taking place. If the product is going to require further manipulation than a pharmacist is required to do the product verification prior to dispensing to a patient. Iowa allows technician-check-technician. The technician must have active Iowa registration, hold national technician certification, have experience as a technician and be trained in technician-check-technician (including medication errors). There shall be a supervising pharmacist. The pharmacy is required to have policies and procedures in place and maintain records. The drug utilization review must be performed by a pharmacist. The medication checked by a technician must be checked by a licensed health care practitioner prior to administration. When utilizing a central fill pharmacy, the originating pharmacy shall be responsible for all dispensing functions. A central fill pharmacy that shares a common central processing unit with the originating pharmacy may perform prospective drug use review. The label on the prescription shall indicate it was filled at a central fill pharmacy and have the name, address, and telephone number of the originating pharmacy. A hospital may implement the InstyMeds dispensing system in the hospital emergency department. Stocking, inventory and monitoring shall be limited to pharmacists, pharmacy technicians, and pharmacist-interns. It should be located in a secure location. The stock shall be limited to acute care drugs for a 72-hour supply except antimicrobials may be dispensed in a quantity to provide the full course of therapy. The prescriber shall provide the patient with consultation. The hospital pharmacist shall review the printout of drugs provided utilizing the InstyMeds dispensing system within 24 hours (or the first day the pharmacy is open) to identify any dispensing errors, to determine dosage appropriateness, and to complete a retrospective drug use review of any antimicrobials dispensed in a quantity greater than a 72-hour supply. Telepharmacy is allowed in Iowa. There shall be a written agreement between the managing pharmacy and telepharmacy site. In the event that a verifying pharmacist is not available or that the audiovisual communication connection between the telepharmacy site and the managing pharmacy is not available, the telepharmacy site shall close. The site shall inform the public it is a telepharmacy site. The telepharmacy site shall be secure. Patient counseling is required utilizing the audiovisual technology employed between the two sites. The label shall include the name, telephone number and address of the telepharmacy site and the name and telephone number of the managing pharmacy. A pharmacist shall monthly inspect the telepharmacy site. A technician working in a telepharmacy site shall have completed a minimum of 2,000 hours and completed training. In an institutional pharmacy, supplies for drugs for use in medical emergencies shall be immediately available pursuant to policies and procedures. All drug storage areas within the facility shall be routinely inspected to ensure that no outdated or unusable items are available for administration and all stock items are properly labeled and stored. Iowa does not allow for delegation to unlicensed persons. Iowa registers technicians.
Michigan: In Michigan, a prescription shall be legible and include the name of the patient, prescriber’s name and address, drug name and strength, the quantity prescribed, directions for use, and number of refills authorized. The label shall include mandatory elements. A consultation is required for each prescription for a drug not previously prescribed for the patient or by request of the patient or agent for any prescription. Consultation is not required if the patient refuses or for prescriptions administered to a patient while the patient is in a medical institution. The elements of the consultation are to encourage intended, positive patient outcomes, necessary and appropriate information regarding safe and effective medication use at the time a prescription is dispensed. The consultation shall be communicated orally and in person, except when the patient or caregiver is not at the pharmacy or when a specific communication barrier prohibits oral communication. In either situation, providing printed material designed to help the patient use the medication safely and effectively satisfies the requirement. Prescription records shall be maintained for 5 years. Prescription drugs or devices which have been dispensed and have left the control of the pharmacist shall not be returned except for pharmacies operated by the department of corrections or county jail, or a pharmacy that participates in the program for the utilization of unused prescription drugs. A pharmacy engaging in centralized prescription processing shall be responsible for each function of the prescription’s processing performed by that pharmacy. A delivering pharmacist shall be responsible for complying with patient counseling. The prescription label for a prescription that was filled by a centralized processing center shall identify each pharmacy that was involved in preparing and delivering a prescription. Both pharmacies shall maintain records. An automated device may be used only in the following locations: pharmacy, hospital, county medical care facility, hospice, nursing home, other skilled nursing facility or office of a dispensing prescriber. The pharmacist or pharmacy personnel shall be responsible for the stocking of the automated device unless located in a dispensing prescriber’s office (then it is the responsibility of the dispensing prescriber). A pharmacist shall review the prescription or medication order before removal of any medication from the system unless it being used as an after-hours cabinet or in place of an emergency kit. Michigan does not allow for delegation to unlicensed persons. Michigan credentials technicians.
Minnesota: In Minnesota, a pharmacist shall examine the patient’s profile record and conduct a prospective drug review. Upon recognizing any drug-related problems, the pharmacist shall take appropriate steps to avoid or resolve the problem. A pharmacy may transfer prescription drug order information for the purpose of refilling a prescription if the information is communicated directly by a licensed pharmacist or registered intern to another licensed pharmacist or registered intern. A pharmacy may transfer prescription drug order information for the purpose of initial filing only for non-controlled substance. There are specific elements to a label. Pharmacies may prepackage and label drugs in convenient quantities for subsequent complete labeling and dispensing. Each prepackaged container shall bear a label providing the name of drug, strength, name of the manufacturer or distributor of the finished dosage form of the drug, a beyond use date, internal control number or date and a physical description including any identification code that may appear on tablets and capsules or a bar code based on the NDC. A consultation is required for new prescriptions. Consultation is not required for inpatients where other licensed health care professionals are authorized to administer the drugs or if the patient has expressed a desire not to receive a consultation. There are mandatory elements to the consultation; however, the pharmacist may vary or omit if in the pharmacist’s professional judgment, it is in the best interest of the patient. The pharmacist shall document variations from the required consultation elements. The consultation discussion shall be in person and may be supplemented with written material. When a prescription for which counseling is required is being mailed or delivered to the patient by common carrier or delivery services, the consultation must still be provided but may be accomplished by providing the written information and the availability of the pharmacist to answer questions through the provision of a toll-free phone number. Pharmacies are prohibited from accepting returns of drugs or medical devices except from a hospital items which were dispensed for hospital inpatient use only. Drugs from nursing home and assisted living facilities can be returned and redispensed if the pharmacist can assure proper storage conditions for the drugs, the facility as 24-hour on-site licensed nursing coverage 7-days a week, the drugs are returned to the same pharmacy which dispensed the drugs, and the integrity of the packaging remains intact. A patient profile record system must be maintained in all pharmacies. Pharmacy records shall be kept not less than 2 years. A pharmacy may perform or outsource centralized prescription drug order filling or centralized prescription drug order processing services. The parties must have the same owner or a written contract outlining the services to be provided. There shall be an agreement to how the parties will comply with federal and state laws. Both pharmacies are to maintain records. The pharmacy that delivers the completed prescription drug order to the patient is responsible for certifying the completed prescription drug order and is responsible for counseling the patient. Minnesota does not allow for delegation to unlicensed persons. Minnesota registers technicians.
Summary of factual data and analytical methodologies:
The Pharmacy Examining Board did a comprehensive review of the practice of pharmacy in order to update the rules to current standards and practices. In addition, the Pharmacy Examining Board reviewed the National Association of Boards of Pharmacy’s model rules, the rules of the surrounding states as well as other states and considered stakeholder input.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:
This rule was posted for economic comments for 14 days. The Pharmacy Examining Board invited those who submitted economic comments to a board meeting to discuss economic concerns.
Fiscal Estimate and Economic Impact Analysis:
The Fiscal Estimate and Economic Impact Analysis is attached.
Effect on small business:
These proposed rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats. The Department’s Regulatory Review Coordinator may be contacted by email at Daniel.Hereth@wisconsin.gov, or by calling (608) 267-2435. Agency contact person:
Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-2377; email at DSPSAdminRules@wisconsin.gov. ---------------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. Chapter 7 is repealed and recreated to read:
PHARMACY PRACTICE
Subchapter I — General
7.01 Definitions. In this chapter:
(1) “Control number” means a unique number used to identify a repackaged drug or drug product in reference to a record that contains NDC, expiration date, and lot number.
(2) “Managing pharmacist” means a pharmacist who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy, and who is personally in full and actual charge of the pharmacy and personnel.
(3) “NDC” means national drug code.
(4) “Repackaging for stock” means transferring a non-sterile drug product from the stock container in which it was distributed by the original manufacturer and placing it into a different stock container as a source for subsequent prescription dispensing without further manipulation of the drug.
(5) “Standing order” means an order transmitted electronically or in writing by a practitioner for a drug or device that does not identify a particular patient at the time it is issued for the purpose of drug or device dispensing or administration to individuals that meet criteria of the order.
7.02 Prescription (1) Requirements. A prescription drug order shall include all of the following:
(a) Date of issue.
(b) First and last name and address of the practitioner.
(c) Prescriptions ordered by a delegate of the practitioner shall include the first and last name of the delegate and the first and last name and address of the practitioner.
(d) Name, strength, and quantity of the drug product or device.
(e) Directions for use of the drug product or device.
(f) Refills, if any.
(g) Symptom or purpose for which the drug is being prescribed if the patient indicates in writing to the practitioner that the patient wants the symptom or purpose for the prescription to be disclosed on the label.
(i) If prescription is issued under s. 118.2925 (3), Stats., the name and address of the school. (j) If prescription is issued under s. 255.07 (2), the name and address of the authorized entity or individual. (k) Practitioner’s written signature, or electronic or digital signature.
(2) Standing order. (a) A prescription pursuant to a standing order shall include all of the following:
1. Date of issue.
2. First and last name and address of the practitioner.
3. Prescriptions ordered by a delegate of the practitioner shall include the first and last name of the delegate and the first and last name and address of the practitioner.
4. Name, strength, and quantity of the drug product or device.
5. Directions for use of the drug product or device.
6. Refills, if any.
8. If prescription is issued under s. 118.2925 (3), Stats., the name and address of the school. 9. If prescription is issued under s. 255.07 (2), the name and address of the authorized entity or individual. 10. Indicate the prescription is pursuant to a standing order.
(b) A copy of the standing order shall be retained under s. Phar 7.11 (1). (3) electronic prescription. (a) Except as provided in s. 89.068 (1) (c) 4., Stats., and as otherwise prohibited by law, a practitioner may transmit a prescription order electronically only if the patient approves the transmission and the prescription order is transmitted to a pharmacy designated by the patient. Prescription orders transmitted by facsimile machine are not considered electronic prescription orders; but rather, written prescription orders. (b) The prescribing practitioner’s electronic signature, or other secure method of validation shall be provided electronically with a prescription order.
(4) Verbal prescription. Verbal prescription orders may be received at a pharmacy via a direct conversation, telephone answering device or voice mail. The verbal prescription shall be reduced to writing or entered into a computer system under s. Phar 7.11 (2) and the prescription record shall indicate the pharmacist responsible for the accuracy of the prescription information. (5) Alterations. Any alterations that modify the original intent of a prescription shall be documented including the identification of the pharmacist responsible for the alteration and the practitioner or practitioner’s delegate who authorized the alteration.
7.03 Drug utilization review. (1) A pharmacist shall complete a drug utilization review by reviewing the patient record prior to dispensing each prescription drug order for all of the following:
(a) Known allergies.
(b) Rational therapy.
