059-2 Wyo. Code R. § 2-4

Current through April 27, 2019

Section 2-4 - Definitions

(a) "Active pharmacy practice" means a pharmacist who engages in the practice of pharmacy, as defined in W.S. § 33-24-124, a minimum of four hundred (400) hours per calendar year.

(b) "Administer" means the direct application of a drug, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by:

(i) A practitioner (or by his or her authorized agent); or

(ii) The patient or research subject at the direction of the practitioner.

(c) "Ancillary kit" means a tamper-evident sealed and secured container or secured automated dispensing device containing drugs.

(d) "Audit trail" means a record showing who has accessed an information technology application and what operations the user performed during a given period.

(e) "Authentication" means verifying the identity of the user prior to allowing access to the information application.

(f) "Automated Dispensing Device" means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing or distribution of medications, and which collects, controls, and maintains all transaction information.

(g) "Board of Pharmacy" or "Board" means the Wyoming State Board of Pharmacy.

(h) "Collaborative pharmacy practice" is that practice of pharmacy whereby one or more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or more practitioners under protocol and in collaboration to provide patient care services to achieve optimal medication use and desired patient outcomes.

(i) "Collaborative practice agreement" means a written voluntary agreement, between a pharmacist and a prescribing practitioner that defines a collaborative practice.

(j) "Compounding" means and includes the preparation, mixing or assembling of a drug or device, and the packaging and labeling incident thereto for sale or dispensing:

(i) As the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of his/her professional practice;

(ii) For the purpose of research, teaching, or chemical analysis; or

(iii) In anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

(iv) Compounding does not include mixing, reconstituting, adding flavoring or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with the labeling.

(k) "Confidential information" means information maintained by the pharmacist in the patient's records, or communicated to the patient as part of patient counseling, which is privileged and may be released only to the patient or, as the patient directs, to those practitioners and other pharmacists where, in the pharmacist's professional judgment, such release is necessary to protect the patient's health and well being, and to such other persons or governmental agencies authorized by law to investigate controlled substance law violations.

(l) "Consultant pharmacist" means a pharmacist who establishes policies and procedures for the distribution and storage of drugs, visits the facility on a regularly scheduled basis, but is not physically present at the facility for a set number of hours on a daily basis, and conducts prospective and retrospective drug utilization reviews, including the identification of problems and recommendations for resolution of identified problems for residents of the facility.

(m) "Deliver" or "delivery" means the actual, constructive or attempted transfer from one person to another of a drug or device, whether or not there is an agency relationship.

(n) "Device" means an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including any component part of accessory, which is required under federal law to bear the label, "Caution: Federal law restricts this device to sale by or on the order of a physician."

(o) "Digital signature" means an electronic identifier that:

(i) Is intended by the party using it to have the same force and effect as a manual signature;

(ii) Is unique to the authorized signer;

(iii) Is capable of verification;

(iv) Is under the sole control of the authorized signer;

(v) Is linked to the prescription in such a manner, that, if the prescription information is changed, the signature is invalidated; and

(vi) Conforms to Wyoming State Statute and Board Rules and Regulations.

(p) "Dispense" means the interpretation, evaluation and implementation of a prescription drug or nonprescription drug under a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to or use by a patient, research subject or an animal.

(q) "Distribute" means the delivery of a drug or device other than by administering or dispensing.

(r) "Dosage form" means the physical formulation or medium in which the product is manufactured and made available for use including, but not limited to, tablets, capsules, oral solutions, aerosols, inhalers, gels, lotions, creams, ointments, transdermals and suppositories.

(s) "Drug" means an article recognized as a drug in any official compendium, or supplement thereto, designated for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals.

(t) "Drug therapy management" means the same as medication therapy management as defined in this Chapter.

(u) "Electronic prescription" means a prescription that is generated on an electronic application and transmitted as an electronic data file.

(v) "Electronic signature" means a method of signing an electronic message that identifies a particular person as the source of the message and indicates the person's approval of the information contained in the message.

(w) "Electronic transmission" means:

(i) Transmission of the digital representation of information from one computer or other similar electronic device to another computer, which is authenticated by a digital signature; or

(ii) Transmission of the electronic representation of information from one computer or other similar electronic device to a facsimile (fax) machine, which is authenticated by an electronic signature.

(x) "Labeling" means the process of preparing and affixing a label to any drug container, exclusive of the labeling by a manufacturer, packager or distributor.

(y) "Medication refill consolidation" means a component of medication therapy management that recognizes the authority of the pharmacist, at the patient's directions, to proactively adjust the medication quantity or refill schedule and to manage a patient's maintenance medications by coordinating the refill schedules, not to exceed the total quantity prescribed, to improve patient outcomes.

(z) "Medication therapy management" (also known as "drug therapy management") is a distinct service or group of services that optimize therapeutic outcomes for individual patients. Medical therapy management (MTM) services are independent of, but can occur in conjunction with, the provision of a medication or a medical device. MTM encompasses a broad range of professional activities and responsibilities within the licensed pharmacist's scope of practice. MTM services may be performed without a collaborative practice agreement. These services may include, but are not limited to, the following, according to the individual needs of the patient:

(i) Performing or obtaining necessary assessments of the patient's health status;

(ii) Formulating a medication treatment plan;

(iii) Selecting, initiating, modifying or administering medication therapy;

(iv) Monitoring and evaluating the patient's response to therapy, including safety and effectiveness;

(v) Performing a comprehensive medication review to identify, resolve and prevent medication-related problems, including adverse drug events;

(vi) Documenting the care delivered and communicating essential information to the patient's other primary care providers;

(vii) Providing verbal education and training designed to enhance patient understanding and appropriate use of his or her medications;

(viii) Providing information, support services and resources designed to enhance patient adherence with his or her therapeutic regimens, such as medication refill consolidation;

(ix) Coordinating and integrating MTM services within the broader health care management services being provided to the patient;

(x) Such other patient care services as may be allowed by law; or

(xi) Ordering, or performing laboratory assessments, and evaluating the response of the patient to therapy, as it directly relates to MTM, provided:
- (A) The pharmacy or service is certified by the US Department of Health and Human Services, as a clinical laboratory under the Clinical Laboratory Improvement Amendments (CLIA); or
- (B) The tests do not otherwise require a physician's order and the pharmacy or service has obtained a CLIA Certificate of Waiver from the US Department of Health and Human Services; and
- (C) The pharmacist is qualified to direct the laboratory.

(aa) "Paper prescription" means a prescription created on paper or computer generated to be printed or transmitted via fax that includes a manual signature.

(bb) "Patient confidences" as used in Wyo. Stat. Ann. § 33-24-101(b)(4)(C) means information transmitted by the prescribing practitioner or agent to the pharmacist or agent for the purpose of treating the patient and information transmitted by the patient or agent to the pharmacist or agent for the purpose of treatment, and includes the patient's name, address, medical condition and drugs lawfully prescribed for the patient. The pharmacist may release otherwise confidential information pertaining to the patient's treatment to a minor's parent or guardian, the patient's third party payor or the patient's agent.

(cc) "Patient counseling" means the verbal communication by the pharmacist of information, to the patient or caregiver, in order to improve therapy by ensuring proper use of drugs and devices. Patient counseling may be supplemented with printed materials.

(dd) "Pharmacist care" (also known as pharmaceutical care) is patient care activities provided by a pharmacist, with or without the dispensing of drugs or devices, intended to achieve positive clinical outcomes and to optimize the patient's health-related quality of life.

(ee) "Pharmacist's collaborative scope of practice" means those duties and limitations of duties agreed upon by pharmacists and the collaborating practitioners (subject to Board approval and applicable law), and includes the limitations implied by the specialty practiced by the collaborating practitioner.

(ff) "Pharmacist-in-Charge" ("PIC") means a pharmacist currently licensed in this state who accepts responsibility for the operation of a pharmacy in conformance with all laws, rules pertinent to the practice of pharmacy and the distribution of drugs.

(gg) "Pharmacy intern" is described in Chapter 3 of these rules.

(hh) "Practitioner" means an individual currently licensed, registered, or otherwise authorized by the jurisdiction in which he/she practices to prescribe drugs in the course of professional practice.

(ii) "Prepackage" means to prepare a drug in a container in advance of actual, immediate need for dispensing, prior to the receipt of an order. Such packaging may be in a single unit dose or unit of use package for use in a unit dose dispensing system or in a container suitable for a traditional dispensing system.

(jj) "Prescription drug" or "legend drug" means a drug which, under federal law, is required to be labeled with one of the following statements:

(i) "Caution: Federal law prohibits dispensing without a prescription";

(ii) "Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian"; or

(iii) "Rx Only."

(kk) "Prescription drug order" means a lawful order of a practitioner for a drug or device for a specific patient.

(ll) "Readily retrievable" means records kept in such a manner that they can be separated out from all other records and produced for review within forty-eight (48) hours.

(mm) "Repackage" means to prepare a single unit dose or unit of use package or traditional dispensing system package for dispensing pursuant to an existing order.

(nn) "State Board," as used in W.S. § 33-24-136(b), shall mean the boards of medicine, dental examiners, nursing, podiatry, optometry and veterinary medicine of the State of Wyoming and their similar counterpart boards of any of the states in the United States of America.

(oo) "Traditional dispensing system" means a drug package system in which individual doses are not packaged in single unit dose packages or unit of use packages.

(pp) "Unit dose dispensing system" means a drug distribution system that is in a pharmacy and uses single unit dose packages or unit of use packages that enable distribution of packaged doses in a manner that preserves the identity and the integrity of the drug.

(qq) "Single Unit Dose" means a package that contains one unit of medication.

(rr) "Unit of use" means a package that provides multiple units of doses separated in a medication card or other similarly designed container.

(ss) "Wholesale distributor" is defined in Chapter 8 of these rules.

059-2 Wyo. Code R. § 2-4

Amended, Eff. 10/31/2017.

Amended, Eff. 12/19/2018.