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Rules of Department of Commerce and Insurance Division 2150—State Board of Registration for the Healing Arts Chapter 5—General Rules

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20 CSR 2150-5.020 Nonpharmacy Dispensing ...... 3 20 CSR 2150-5.025 Administration of Per Protocol...... 3 20 CSR 2150-5.026 General Provisions...... 5 20 CSR 2150-5.028 Services By Protocol ...... 5 20 CSR 2150-5.029 Authority to Prescribe Pursuant to Section 338.665 ...... 8 20 CSR 2150-5.030 , Rehabilitation Services, or Both ...... 8 20 CSR 2150-5.100 Collaborative Practice Arrangement with Nurses ...... 9

JOHN R. ASHCROFT (6/30/21) CODE OF STATE REGULATIONS 1 Secretary of State Chapter 5—General Rules 20 CSR 2150-5

Title 20—DEPARTMENT OF (D) The physician’s name and address; and (A) Vaccines must be administered in accor- COMMERCE AND INSURANCE (E) The exact name and strength of the dance with current treatment guidelines estab- Division 2150—State Board of dispensed and, in the case of a generic lished by the Centers for Control Registration for the Healing Arts drug, the name of the manufacturer or (CDC) and the manufacturer’s guidelines, Chapter 5—General Rules repackager of the drug. It shall be a violation provided CDC guidelines shall control in the of this rule for a physician to dispense a event of a conflict. Vaccines may not be 20 CSR 2150-5.020 Nonpharmacy Dispens- generic drug and affix to the label any trade administered to persons under seven (7) years ing name or other identification that would serve of age unless otherwise authorized by law. to misrepresent the source of the drug. (B) shall ensure compliance PURPOSE: This rule provides information with all state and federal laws and regulations (5) Physicians may dispense only to individu- concerning the general responsibilities of a pertaining to Information Statements als with whom they have established a physi- and informed consent requirements. physician who elects to dispense cian/ relationship. It shall be a viola- from his/her office or . (C) Vaccines must be stored in accordance tion of this rule for a physician to dispense with CDC guidelines/recommendations and medication at the order of any other physician (1) Physicians must provide the free- within the manufacturer’s labeled require- not registered to practice at that same loca- ments, including, when vaccinating outside of dom of choice concerning the source of tion. and devices prescribed during the of a . (D) A pharmacist may only delegate vac- the physician/patient relationship. This (6) It is not the intention of this rule to inter- cine administration to an intern pharmacist or means that no physician may require, as a fere with any recognized system for physician qualified pharmacy technician who has met condition of the physician/patient relation- operated by any accredited located within the borders of Missouri the qualifications of subsections (3)(B) and ship, that the patient only receive drugs dis- (C) of this rule and is working under the pensed directly from the physician’s office. nor is it the intention of this rule to interfere with the individual physician’s appropriate direct supervision of a pharmacist qualified By the same token, a physician cannot require use of professional samples nor is it the inten- to administer vaccines. Proof of an intern’s or any patient to use the services of any particu- tion of this rule to interfere in any way with qualified pharmacy technician’s compliance lar pharmacy. the physician’s right to directly administer with subsections (3)(B) and (C) must be drugs or to any patient. maintained by both the supervising pharma- (2) Physicians must provide appropriate cist and the intern pharmacist/qualifying supervision to personnel employed to assist in (7) Whenever dispensing takes place, appro- pharmacy technician for a minimum of two the dispensing of drugs and devices from the priate records shall be maintained. These (2) years. physician’s office. records must be adequate to show the name (E) For purposes of this rule, a “qualified (A) When the dispensing personnel is of the patient, the name and strength of the pharmacy technician” is defined as a current- either a licensed acting drug dispensed, the quantity, the dose, etc. A ly registered Missouri pharmacy technician within the scope of a supervision agreement separate log must be maintained for con- who— or licensed nurse acting within the scope of a trolled substance dispensing. 1. Holds an active pharmacy technician collaborative practice arrangement, the physi- certification issued by a certification entity cian is not required to be present. AUTHORITY: section 334.125, RSMo 2000.* accredited by the National Commission for (B) In all other instances, it shall be a vio- This rule originally filed as 4 CSR 150-5.020. Certifying Agencies; Original rule filed May 11, 1984, effective lation of this rule for any physician to permit 2. Has an initial and, if applicable, Sept. 14, 1984. Moved to 20 CSR 2150- the dispensing of medication from his/her annual documented assessment of competen- 5.020, effective Aug. 28, 2006. Amended: clinic or office when that physician is not pre- cy in vaccine administration; and Filed Aug. 14, 2009, effective Jan. 30, 2010. sent unless another physician duly licensed 3. Has assisted in the practice of phar- macy as a registered/licensed pharmacy tech- under the provisions of Chapter 334, RSMo, *Original authority: 334.125, RSMo 1959, amended is present. 1993, 1995. nician in the state of Missouri or another U.S. state or territory for a minimum of one (3) Physicians who elect to dispense medica- (1) year. tion must comply with the regulations gov- 20 CSR 2150-5.025 Administration of Vac- (2) The authorizing physician is responsible erning the types of container that may be used cines Per Protocol for the oversight of, and accepts responsibili- to repackage prescription drugs as specified PURPOSE: This rule establishes the proce- ty for, the vaccines administered by the phar- by federal law or rule unless the individual to dures for pharmacists to administer vaccines macist. whom the drug is dispensed gives written per written protocol with a physician. authorization for the container to be other- (3) Pharmacist Qualifications. Pharmacists wise. (1) A pharmacist may administer vaccines administering vaccines by protocol as autho- authorized by Chapter 338, RSMo, pursuant rized by Chapter 338, RSMo, must first file (4) All drugs dispensed by a physician shall to a written protocol with a Missouri licensed a Notification of Intent (NOI) to administer bear a label permanently affixed to the exte- physician who is actively engaged in the prac- vaccines with the Missouri Board of Pharma- rior of the drug container which sets forth the tice of . Unless otherwise restricted cy. To file a NOI, a pharmacist must— following information: by the governing protocol, vaccines may be (A) Hold a current Missouri pharmacist (A) The date; administered at any Missouri licensed phar- license; (B) The patient’s name; macy or at any non-pharmacy location as (B) Hold a current healthcare provider (C) Complete directions for usage; allowed in the governing protocol. level cardiopulmonary resuscitation (CPR) or

JOHN R. ASHCROFT (6/30/21) CODE OF STATE REGULATIONS 3 Secretary of State 20 CSR 2150-5—DEPARTMENT OF COMMERCE AND INSURANCE Division 2150—State Board of Registration for the Healing Arts

basic life support (BLS) certification issued 9. Procedures for disposing of used and 1. If the vaccine is administered on by the American Association, the contaminated supplies; behalf of a pharmacy, both the pharmacy and American Red Cross, or an equivalent orga- 10. Authorization to administer vaccines the administering pharmacist shall ensure the nization. The qualifying BLS or CPR certifi- at a non-pharmacy location, if applicable; records required by subsection (5)(A) are cation program must have included a live in- 11. Record-keeping requirements and any promptly delivered to and maintained at the person skills assessment; and required notification procedures; and pharmacy separate from the pharmacy’s pre- (C) Have successfully completed a certifi- 12. A provision allowing termination of scription files; cate program in administering vaccines the protocol at any time at the request of any 2. If the vaccine is not administered on accredited by the Accreditation Council for party. behalf of a pharmacy, records must be main- Pharmacy Education (ACPE), provided by an (B) The protocol, and any subsequent tained by the administering or supervising ACPE, or regionally accredited pharmacy or amendments or alterations, must be reviewed pharmacist at an address identified in the pro- medical school/college or approved by the and manually or electronically signed and tocol prior to administering the vaccine; Board of Pharmacy. The required certificate dated by the pharmacist and authorizing 3. Prescription records must be main- program must include a live/in-person train- physician prior to its implementation, signi- tained as required by Chapter 338, RSMo, ing component and include instruction in: fying that both are aware of its contents and and the rules of the board; and 1. Current CDC guidelines and recom- agree to follow the terms of the protocol. A 4. Records required by this rule must be mendations for vaccines authorized by Chap- copy of the protocol must be maintained by maintained for two (2) years and made avail- ter 338, RSMo, including, recommended both the pharmacist and the authorizing able for inspecting and copying by the State immunization schedules; physician for a minimum of eight (8) years Board of Pharmacy or the State Board of Reg- 2. Basic and vaccine pro- after termination of the protocol. istration for the Healing Arts and/or their tection; (C) Additional pharmacists or immuniza- authorized representatives. Records main- 3. and techniques for vac- tion locations may be added to an existing tained at a pharmacy must be produced dur- cine administration, including, hands-on protocol if the amendment is signed and ing an inspection by the board and/or their training in intramuscular, intradermal, subcu- dated by the authorizing physician(s) and, if authorized representatives. Records not main- taneous and nasal administration routes, and applicable, any newly added pharmacist(s). tained at a pharmacy must be produced with- other common routes of vaccine administra- Existing pharmacists are not required to re- in three (3) business days after a request from tion; sign the protocol unless other protocol terms the State Board of Pharmacy or the State 4. Pre- and post- vaccine screening or or provisions are changed. Board of Registration for the Healing Arts assessment; and and/or their authorized representatives. Fail- 5. Identifying and treating adverse (5) Record Keeping. ure to maintain or produce records as provid- immunization reactions; (A) The pharmacist shall ensure a record is ed by this rule shall constitute grounds for (D) Notifications of Intent must be filed on maintained for each vaccine administered by discipline. the board’s website or on a form approved by protocol that includes: the board. 1. The patient’s name, address, and date (6) Notification of Immunizations. Pharma- of birth; cists immunizing by protocol must— (4) Protocol Requirements. 2. The date, route, and anatomic site of (A) Notify all persons or entities as (A) In addition to filing a NOI, pharma- the administration; required by state and federal law; cists administering vaccines under this rule 3. The vaccine’s name, dose, manufac- (B) Notify the protocol physician as must first enter into a written protocol with a turer, lot number, and expiration date; required by the governing protocol; Missouri licensed physician. The written pro- 4. The name and address of the patient’s (C) Notify the patient’s primary care tocol may be valid for a time period not to primary care provider, as provided by provider as required by Chapter 338, RSMo; exceed one (1) year. The protocol must be the patient; and renewed annually and include the following: 5. The identity of the administering (D) Notify the patient’s primary health 1. The identity of the participating phar- pharmacist or, if applicable, the identity of care provider and, if different, the protocol macist and physician; the administering intern pharmacist or quali- physician, within twenty-four (24) hours after 2. Time period of the protocol; fied pharmacy technician and supervising learning of any adverse event or reaction 3. Authorized vaccines; pharmacist; and experienced by the patient. Adverse events or 4. The patient or groups of patients 6. The nature of any adverse reaction reactions must also be reported to the Vaccine authorized for vaccination; and who was notified, if applicable. Adverse Event Reporting System (VAERS) or 5. Allowed routes and anatomic sites of (B) Within seventy-two (72) hours after a its successor, within thirty (30) days. administration; vaccine is administered, a prescription must (E) Unless otherwise provided by the gov- 6. If applicable, authorization to create a be obtained from the authorizing physician erning protocol, notification may be made via prescription for each administration under the for the drug dispensed or a prescription must a common electronic medication record that physician’s name; be created in the physician’s name document- is accessible to and shared by both the physi- 7. Emergency response procedures, ing the dispensing as authorized by protocol. cian and pharmacist. Proof of notification including, but not limited to, procedures for Notwithstanding any other provision of this must be maintained in the pharmacist’s handling/addressing adverse reactions, ana- rule, prescription records must be maintained records as provided in subsection (5)(C) of phylactic reactions, and accidental needle as provided by Chapter 338, RSMo, and the this rule. sticks; rules of the board. 8. The length of time the pharmacist (C) The records required by this rule must (7) Notification of Intent Renewal. A Notifi- must observe an individual for adverse events be securely and confidentially maintained as cation of Intent (NOI) to immunize by proto- following an injection; follows: col must be renewed biennially with the

4 CODE OF STATE REGULATIONS (6/30/21) JOHN R. ASHCROFT Secretary of State Chapter 5—General Rules 20 CSR 2150-5

immunizing pharmacist’s Missouri pharma- governing medication therapy services by (F) Prescription order for medication ther- cist license. To renew a NOI, pharmacists pharmacists. apeutic plan—A lawful order that is issued by must— the authorizing physician within the scope of (A) Have a current healthcare provider car- (1) Definitions. The following definitions his/her professional practice for the provision diopulmonary resuscitation (CPR) or basic shall apply for purposes of 20 CSR 2150- of medication therapy services by a pharma- life support (BLS) certification that complies 5.026 to 20 CSR 2150-5.028: cist for a specific patient, including, patients with subsection (3)(B) of this rule; and (A) Authorizing physician(s)—The physi- of a entity; and (B) Have completed a minimum of two (2) cian identified in the written protocol as (G) Protocol—A medication therapy proto- hours of continuing education (0.2 CEU) authorizing the pharmacist to provide medi- col, as defined herein. related to administering vaccines or CDC cation therapy services; immunization guidelines in a course approved (B) Health care entity—For purposes of (2) The provisions of 20 CSR 2150-5.026 to by the Board of Pharmacy or provided by an this rule, a health care entity shall be defined 20 CSR 2150-5.028 and 20 CSR 2220-6.060 ACPE accredited continuing education as any entity or organization that is licensed to 20 CSR 2220-6.080 shall only be deemed provider within the applicable pharmacist or certified by the state or federal government applicable to persons or entities under the biennial renewal period (November 1 to as a , facility, ambulatory jurisdiction of the Missouri State Board of October 31 of the immediately preceding surgical center, home, long-term care Registration for the Healing Arts and the even numbered years). facility, residential care facility, assisted liv- Missouri State Board of Pharmacy, as estab- lished by Chapter 334, RSMo, and Chapter (C) The required continuing education ing facility, intermediate care facility, skilled 338, RSMo. (CE) shall be governed by 20 CSR 2220- nursing facility, or a habilitation center as 7.080 and may be used to satisfy the phar- defined by Chapter 630, RSMo, and that is AUTHORITY: section 334.125, RSMo 2000, macist’s biennial continuing education required to maintain patient medical records and sections 338.010 and 338.220, RSMo requirements. The initial training program by state or federal law; Supp. 2011.* Original rule filed Jan. 13, required by section (3) of this rule may be (C) Medication therapy protocol—A writ- 2012, effective Aug. 30, 2012. used to satisfy the CE requirements of this ten agreement between a physician and a subsection if the training program was com- pharmacist for the provision of medication *Original authority: 334.125, RSMo 1959, amended pleted within the applicable pharmacist bien- therapy services. A medication therapy proto- 1993, 1995; 338.010, RSMo 1939, amended 1989, 1990, nial renewal cycle. 2007, 2009, 2011; and 338.220, RSMo 1951, amended col shall comply with the provisions of 20 1969, 1981, 1989, 1997, 1999, 2001, 2004, 2007, 2009, CSR 2150-5.028; 2011. (8) A qualified pharmacy technician immu- (D) Medication therapy services—The nizing pursuant to this rule must be super- designing, initiating, implementing, or moni- 20 CSR 2150-5.028 Medication Therapy vised by a Missouri-licensed pharmacist who toring of a plan to monitor the medication Services By Protocol is authorized to immunize by protocol and therapy or device usage of a specific patient, who is physically present on-site when the or to enhance medication therapeutic out- vaccine is administered. PURPOSE: This rule establishes procedures comes of a specific patient, by a pharmacist for the provision of medication therapy ser- who has authority to initiate or implement a AUTHORITY: section 334.125, RSMo 2016, vices by protocol, as authorized by section modification of the patient’s medication thera- 338.010, RSMo. and sections 338.010 and 338.220, RSMo py or device usage pursuant to a medication Supp. 2020.* Emergency rule filed Oct. 24, therapy protocol. For purposes of 20 CSR (1) Except as otherwise provided herein, a 2007, effective Nov. 3, 2007, expired April 2150-5.026 to 20 CSR 2150-5.028, modifica- pharmacist who holds a certificate of medica- 30, 2008. Original rule filed Oct. 24, 2007, tion shall include selecting a new, different, or tion therapeutic plan authority from the Mis- effective May 30, 2008. Emergency amend- additional medication or device, discontinuing souri State Board of Pharmacy shall be autho- ment filed Oct. 22, 2009, effective Nov. 1, a current medication or device, or selecting a rized to provide medication therapy services 2009, expired April 29, 2010. Amended: Filed new, different, or additional strength, dose, in Missouri if the pharmacist— Oct. 22, 2009, effective June 30, 2010. Emer- dosage form, dosage schedule, or route of (A) Holds a current Missouri pharmacist gency amendment filed Aug. 20, 2018, effec- administration for a current medication or license that is not under discipline with the tive Sept. 30, 2018, expired March 28, 2019. device, and implementing such selection(s). Missouri State Board of Pharmacy; and Amended: Filed Aug. 20, 2018, effective Feb. Medication therapy services shall not include (B) Has entered into a written protocol 28, 2019. Emergency amendment filed Jan. 4, the sole act of dispensing a drug or device pur- with a Missouri licensed physician that com- 2021, effective Jan. 19, 2021, expired July suant to a valid prescription for the product, plies with the requirements of this rule. 17, 2021. Amended: Filed Jan. 4, 2021, effec- generic substitutions made pursuant to section tive July 30, 2021. (2) General Requirements. A pharmacist may 338.056, RSMo, or medication therapy man- provide medication therapy services only *Original authority: 334.125, RSMo 1959, amended agement that does not include the initiation or with current certification and as authorized 1993, 1995, 2014; 338.010, RSMo 1939, amended 1951, implementation of a modification of medica- by the protocol and the authorizing physician. 1989, 1990, 2007, 2009, 2011, 2014, 2017, 2018, 2019; tion therapy, as provided herein; A pharmacist providing medication therapy and 338.220, RSMo 1951, amended 1969, 1981, 1989, (E) Pharmacy resident—A Missouri 1997, 1999, 2001, 2004, 2007, 2009, 2011, 2013, 2014, services pursuant to this rule shall comply 2020. licensed pharmacist enrolled in a with the following: training program accredited by the American (A) Prior to providing medication therapy Society of Health-System Pharmacists or a services, the pharmacist shall receive a pre- 20 CSR 2150-5.026 General Provisions residency training program with a valid appli- scription order for a medication therapeutic cation for accreditation pending with the plan from the authorizing physician for a spe- PURPOSE: This rule establishes definitions American Society of Health-System Pharma- cific patient which authorizes the pharmacist for 20 CSR 2150-5.026 to 20 CSR 2150-5.028 cists; to perform medication therapy services.

JOHN R. ASHCROFT (6/30/21) CODE OF STATE REGULATIONS 5 Secretary of State 20 CSR 2150-5—DEPARTMENT OF COMMERCE AND INSURANCE Division 2150—State Board of Registration for the Healing Arts

Except as otherwise provided in subsection the pharmacist’s medication therapy service any conflict arises regarding the professional (2)(B) of this rule, the prescription order for activities regularly, but not less than once judgment of the pharmacist and physician a medication therapeutic plan shall be valid every three (3) months. If the pharmacist is with regard to the subject of the medication for no more than one (1) year and shall providing medication therapy services for, or therapy services, the physician has ultimate include: on behalf of, a health care entity, the review authority; 1. The patient’s name, address, and date requirements shall be satisfied if the pharma- 7. A statement that the pharmacist shall of birth; cist’s work and services are reviewed every not delegate the responsibility of medication 2. The date the prescription order for a three (3) months by a clinical care committee, therapy services to another person; medication therapeutic plan is issued; pharmacy and therapeutics committee, or a 8. A description of any authority grant- 3. The clinical indication for medication reviewing body/committee of the health care ed to the pharmacist to administer any drug therapy services; entity that includes a Missouri-licensed or medication including the identification of 4. The length of time for providing med- physician. The review required by this sub- any such drug, medication, or device; ication therapy services, if less than one (1) section may be accomplished in person or by 9. A description of drug therapy related electronic means. year; and patient assessment procedures or testing that (E) The practice location of the authorizing 5. The authorizing physician’s name and may be ordered or performed by the pharma- address; physician shall be no further than fifty (50) cist, including any authority to order or per- (B) A prescription order for a medication miles by road from the pharmacist identified form routine or other laboratory testing; therapeutic plan may be transmitted orally, in the written protocol. 10. Provisions for allowing the pharma- electronically, or in writing. If an oral pre- (F) An authorizing physician shall notify scription order for a medication therapeutic the Missouri State Board of Registration for cist to access the patient’s medical records for plan is issued, all information required under the Healing Arts of a written protocol for purposes of providing medication therapy ser- subsection (2)(A) of this rule shall be docu- medication therapy services entered with a vices; mented by the pharmacist and maintained in pharmacist at each renewal of the authorizing 11. A provision for providing the autho- the patient’s record in accordance with sec- physician’s license. rizing physician access to patient records for tion (7) of this rule; medication therapy services provided by the (C) The pharmacist shall review relevant (4) Protocol Requirements. pharmacist for patients of the authorizing prescription records, patient profiles, patient (A) The medication therapy services per- physician; medical records, or other medical informa- formed by a pharmacist pursuant to the pro- 12. Provisions establishing a course of tion to determine the services to be rendered; tocol shall be within the authorizing physi- action the pharmacist is authorized to follow and cian’s scope of practice and within the skill, to address emergency situations, including, (D) In lieu of compliance with 20 CSR education, training, and competence of both but not limited to, anaphylactic or other 2220-2.018, prescription orders for medica- the authorizing physician and the pharmacist. adverse medication reactions, adverse needle tion therapy services shall comply with the (B) The written protocol between the sticks, or other adverse events; provisions of this rule, provided the pharma- authorizing physician and pharmacist shall, at 13. Criteria for timely communication cist shall maintain the prescription order in a minimum, include the following: from the authorizing physician to the phar- the patient record required by section (7) of 1. The identity and signatures of the macist and from the pharmacist to the autho- this rule and shall document any change or authorizing physician and pharmacist; rizing physician, not inconsistent with the alteration made to the prescription ordered 2. The effective dates of the protocol; provisions of this rule; based on contact with the prescriber in the 3. A statement of clinical conditions, 14. The notification requirements applicable patient record. diagnoses, , and specific drugs, or required by section (5) of this rule; and drug categories included in the written proto- 15. The method for reviewing the phar- (3) Authorizing Physician Requirements. col and the type of medication therapy ser- macist’s medication therapy work or services (A) The authorizing physician shall be vices allowed in each case; by the authorizing physician, as required by actively engaged in the practice of medicine 4. A statement of the methods, proce- subsection (3)(D) of this rule. in the state of Missouri and shall hold a cur- dures, decision criteria, and plan the pharma- (C) The written protocol shall include a rent and unrestricted Missouri physician cist is to follow when conducting medication description of medication therapy services the license pursuant to Chapter 334, RSMo. therapy services; pharmacist is authorized to render or provide. (B) The authorizing physician shall be Such services may include: responsible for the oversight of the medica- 5. Procedures for documenting medica- tion therapy services provided by the phar- tion therapy decisions made by the pharma- 1. Assessing patient specific data and macist that are authorized by protocol. The cist and a plan for communication, feedback, issues; authorizing physician shall also consider the and reporting to the authorizing physician 2. Establishing medication therapeutic level of skill, education, training, and com- concerning specific decisions made; goals or medication related action plans for petence of the pharmacist and ensure that the 6. A mechanism and procedure that identified medical conditions and medication activities authorized by the protocol are con- allows the authorizing physician to override, related concerns; sistent with the pharmacist’s level of skill, rescind, modify, or otherwise amend the pro- 3. Assessing and addressing adverse education, training, and competence. tocol. All modifications or amendments to reactions and adverse drug events; (C) The written protocol shall be reviewed the protocol shall be documented in writing, 4. Modifying and medica- and signed by the pharmacist and the autho- signed, and dated by all involved parties prior tion regimens; rizing physician at least annually and revised to the implementation of such modification or 5. Evaluating treatment progress; as needed. The authorizing physician and amendment. The protocol may be immediate- 6. Assessing and monitoring pharma- pharmacist shall document the date of the ly rescinded by the authorizing physician or cokinetic and pharmacodynamic changes in annual review on the written protocol. the pharmacist with or without cause, provid- medication regimen reviews; (D) The authorizing physician shall review ed the rescission is documented in writing. If 7. Medication reconciliation;

6 CODE OF STATE REGULATIONS (6/30/21) JOHN R. ASHCROFT Secretary of State Chapter 5—General Rules 20 CSR 2150-5

8. Drug utilization review; American Society of Health-System Pharma- with the provisions of this subsection if the 9. Formulating and documenting per- cists; and modification is documented in a patient med- sonal medication records; 3. The resident is providing medication ical record that the health care entity is 10. Documenting clinical outcomes; therapy services under the supervision of a required to maintain under state or federal 11. Interpreting, monitoring, and assess- Missouri pharmacist certified by the Missouri law. ing patient test results; State Board of Pharmacy to perform medica- (B) The pharmacist shall not modify any 12. Initiation of drug therapy, as autho- tion therapy services. controlled substance prescription. A pre- rized by protocol; and (J) The provisions of subsection (4)(I) shall scription from the authorizing physician shall 13. Patient education and counseling. only apply to medication therapy services be required to modify a controlled substance. (D) The protocol required by this section provided by a pharmacist as part of his/her (C) For purposes of 20 CSR 2150-5.026 shall be signed and dated by the authorizing residency training. and 20 CSR 2150-5.028, modification of physician and the pharmacist. If the protocol medication therapy shall include selecting a includes multiple authorizing physicians or (5) Notification Requirements. A pharmacist new, different, or additional medication or participating pharmacists, a separate protocol shall comply with the following notification device, discontinuing a current medication or shall not be required for each physician or requirements: device, or selecting a new, different, or addi- pharmacist if all authorizing physicians and (A) Within twenty-four (24) hours after tional strength, dose, dosage form, dosage learning of an anaphylactic or other adverse pharmacists have signed and dated a state- schedule, or route of administration for a cur- medication reaction, adverse needle stick, or ment agreeing to be governed by the terms of other adverse event experienced by a patient, rent medication or device, and implementing the written protocol. the pharmacist shall notify the patient’s such selection(s). Medication therapy ser- (E) Any revisions, modifications, or authorizing physician or an authorized vices shall not include the sole act of dis- amendments to the protocol must be in writ- designee of the authorizing physician; pensing a drug or device pursuant to a valid ing. The authorizing physician shall prompt- (B) The pharmacist shall notify the autho- prescription for the product or generic substi- ly notify the pharmacist of any such revision, rizing physician or an authorized designee of tutions made pursuant to section 338.056, modification, or amendment and shall main- the authorizing physician in the written pro- RSMo. tain documentation of the notification, tocol of any modification of therapy, within including the date such notification was twenty-four (24) hours, provided the protocol (7) Record Keeping. made. The authorizing physician may dele- may include more stringent notification (A) A pharmacist shall document and gate the notification requirements of this sub- requirements; maintain an adequate patient record of medi- section to an authorized designee, provided (C) A pharmacist shall be deemed in com- cation therapy services provided to each the physician shall be ultimately responsible pliance with the notification requirements of patient. The records may be maintained in for compliance with the notification require- this rule if the pharmacist is providing medi- electronic format provided the records are ments. cation therapy services for, or on behalf of, a capable of being printed for review by the (F) A pharmacist shall not be authorized to health care entity, as defined by this rule, and Missouri State Board of Registration for the adjust, change, or modify any controlled sub- documentation of the notifications required Healing Arts and the Missouri State Board of by this section is recorded in a patient medi- stance prescribed for a patient, except as Pharmacy. An adequate and complete patient cal record that is required to be maintained by record shall include documentation of the fol- authorized by state or federal law. the health care entity pursuant to state or fed- (G) The protocol shall be maintained by eral law; and lowing: the authorizing physician and the pharmacist (D) Notifications required by this section 1. The identification of the patient, for a minimum of eight (8) years after termi- shall be in writing unless otherwise autho- including, name, birthdate, address, and tele- nation of the protocol. The protocol may be rized by the authorizing physician. phone number; maintained electronically. 2. The date(s) of any patient visit or (H) A protocol shall automatically and (6) Modifying Drug Therapy. consultation, including the reason for any immediately terminate if the pharmacist ceas- (A) A pharmacist may be authorized by such visit/consultation; es to maintain an active Missouri pharmacist protocol to modify a patient’s non-controlled 3. Any pertinent assessments, observa- license, the authorizing physician is deceased, substance medication therapy, subject to the tions, or findings; or if the authorizing physician fails to main- following: 4. Any diagnostic testing recommended tain an active, unrestricted Missouri physi- 1. If the pharmacist modifies medication or performed; cian license. therapy and a medication or device is to be 5. The name of any medication or (I) Pharmacy Residents. If specifically dispensed, the pharmacist shall create a pre- device modified and the strength, dose, authorized by the protocol, a pharmacy resi- scription for the medication or device modi- dosage schedule, dosage form, and route of dent shall be authorized to perform medica- fied under the authorizing physician’s name. administration of any medication modified or tion therapy services under the written proto- Such prescription may be dispensed by a administered; col of a Missouri pharmacist in lieu of an licensed pharmacy and shall be maintained in 6. Referrals to the authorizing physi- individual protocol, if— the prescription records of the dispensing cian; 1. The resident holds a certificate of pharmacy as provided by the rules of the Mis- 7. Referrals for emergency care; medication therapeutic plan authority from souri State Board of Pharmacy; and 8. Any contact with the authorizing the Missouri State Board of Pharmacy; 2. If the pharmacist modifies medication physician concerning the patient’s treatment 2. The resident is enrolled in a residen- therapy or a device, the pharmacist shall doc- or medication therapy services plan; cy training program accredited by the Amer- ument such modification according to section 9. Any informed consent for procedures, ican Society of Health-System Pharmacists or (7) of this rule. Pharmacists providing medi- medications, or devices; and a residency training program with a valid cation therapy services for patients of a health 10. Any consultation with any other application for accreditation pending with the care entity shall be deemed in compliance treatment provider for the patient and the

JOHN R. ASHCROFT (6/30/21) CODE OF STATE REGULATIONS 7 Secretary of State 20 CSR 2150-5—DEPARTMENT OF COMMERCE AND INSURANCE Division 2150—State Board of Registration for the Healing Arts

results of such consultation. for the Healing Arts and the Missouri State Board of Pharmacy governing prescribing and (B) Pharmacist Record Retention. Except Board of Pharmacy separately retain the right record-keeping, including, but not limited to, as otherwise provided herein, records and duty to discipline their respective 20 CSR 2220-2.018. Pharmacists may pro- required to be maintained by a pharmacist licensees for violations of any state or feder- vide a prescription to the patient or transmit pursuant to this rule shall be maintained al statutes, rules, or regulations regardless of a prescription for that patient to a pharmacy securely and confidentially for a minimum of the licensee’s participation in a protocol for dispensing. seven (7) years after termination of the proto- agreement. col unless more stringent requirements are (4) Patient medical records. Prescribing phar- established for record keeping under state or (13) The provisions of 20 CSR 2150-5.026 to macists shall maintain an adequate and com- federal law. All records required to be main- 20 CSR 2150-5.028 and 20 CSR 2220-6.060 plete patient for each patient tained by the pharmacist by this rule shall be to 20 CSR 2220-6.080 shall only be deemed that documents the care provided. Patient maintained by the pharmacist at an address applicable to persons or entities under the medical records must be individually retriev- that shall be identified in the written proto- jurisdiction of the Missouri State Board of able. col. Registration for the Healing Arts and the (A) At a minimum, the required patient (C) Physician Record Retention. Except as Missouri State Board of Pharmacy, as estab- medical record must include: otherwise provided herein, records required lished by Chapter 334, RSMo, and Chapter 1. The patient’s name, birthdate, to be maintained by the authorizing physician 338, RSMo. address and telephone number; pursuant to this rule shall be maintained 2. The date(s) the patient was seen; securely and confidentially for a minimum of AUTHORITY: section 334.125, RSMo 2000, and sections 338.010, 338.140.1., and 3. The patient’s primary care provider, seven (7) years after termination of the proto- if provided; col unless more stringent requirements are 338.380, RSMo Supp. 2011.* Original rule filed Jan. 13, 2012, effective Aug. 30, 2012. 4. Documentation of the patient screen- established for record keeping pursuant to ing as required by section (3) of this rule; state or federal law. *Original authority: 334.125, RSMo 1959, amended 5. Any pertinent medical or medication 1993, 1995; 338.010, RSMo 1939, amended 1989, 1990, (8) Production of Records. Records main- information/history; 2007, 2009, 2011; 338.140, RSMo 1939, amended 1981, 6. The name and dosage of any medica- tained at a pharmacy must be produced during 1989, 1997, 2011; and 338.380, RSMo 2007. an inspection or investigation by the Missouri tion prescribed; State Board of Pharmacy, Missouri State 7. Any recommended medication treat- Board of Registration for the Healing Arts, or 20 CSR 2150-5.029 Pharmacist Authority ment plan(s) or follow-up consultation(s); their authorized representatives, as requested to Prescribe Pursuant to Section 338.665 and by the respective board or the board’s 8. Any healthcare provider referrals. designee. Records not maintained at a phar- PURPOSE: This rule establishes require- (B) Patient medical records must be macy shall be produced within three (3) busi- ments for pharmacists prescribing as autho- securely and confidentially maintained in ness days after a request from the Missouri rized by section 338.665, RSMo. compliance with applicable state and federal State Board of Pharmacy, Missouri State law. At a minimum, patient medical records Board of Registration for the Healing Arts, (1) Definitions. must be maintained for five (5) years from and/or its authorized representative. Failure (A) A nicotine replacement therapy prod- the date created. Records maintained at a to maintain or produce records as provided by uct; as defined by section 338.665, RSMo. pharmacy must be produced immediately or this rule shall constitute grounds for disci- within two (2) hours of a request from the pline. (2) Training. Pharmacists prescribing must Board of Pharmacy or an authorized designee be competent to perform the services provid- of the Board of Pharmacy. Records not main- (9) Nothing in this rule shall be construed to ed and shall maintain ongoing/continued tained at a pharmacy must be produced with- permit of any condition by competency. in three (3) business days of a request from a pharmacist or the independent issuing of a the Board of Pharmacy. prescription by a pharmacist. (3) Pharmacist prescribing and patient care activities must be safely and properly per- AUTHORITY: section 334.125, RSMo 2016, (10) A pharmacist shall not violate or prac- formed. and sections 338.010 and 338.665, RSMo tice in a manner inconsistent with the provi- (A) Pharmacists shall collect patient or Supp. 2019.* Original rule filed March 9, sions of this rule or a written protocol. A to allow the pharmacist to 2020, effective Oct. 30, 2020. pharmacist’s failure to abide by the require- properly assess the patient and safely provide ments of this rule or the provisions of a writ- patient care. Prior to prescribing, the phar- *Original authority: 334.125, RSMo 1959, amended ten protocol shall be subject to disciplinary 1993, 1995, 2014; 338.010, RSMo 1939, amended 1951, macist shall use a screening procedure based action pursuant to the provisions of Chapter 1989, 1990, 2007, 2009, 2011, 2014, 2017, 2018, 2019; on generally accepted clinical guidelines to 338, RSMo. and 338.665, RSMo 2019. identify appropriate patients for treatment. (11) The requirements of this rule shall not The pharmacist shall refer high-risk patients apply to the administration of vaccines pur- or patients with a contraindication to the 20 CSR 2150-5.030 Physical Therapy, suant to protocol as governed by 20 CSR patient’s primary care provider or an appro- Rehabilitation Services, or Both 2150-5.025 or the administration of medica- priate healthcare provider, as deemed neces- tion by protocol as governed by 20 CSR sary or appropriate. PURPOSE: This rule provides information 2220-6.040. (B) In addition to this rule, pharmacists concerning the disclosure of a physician’s shall comply with all applicable provisions of pecuniary interest in a physical therapy or (12) The Missouri State Board of Registration Chapter 338, RSMo, and the rules of the rehabilitation service as directed by section

8 CODE OF STATE REGULATIONS (6/30/21) JOHN R. ASHCROFT Secretary of State Chapter 5—General Rules 20 CSR 2150-5

334.100.2(21), RSMo. Addictions Act” (IATOA) pursuant to sections APRN who provides health care services 334.104 and 630.875, RSMo. that include the diagnosis and initiation of (1) Pursuant to the authority granted in sec- treatment for acutely or chronically ill or tion 334.100.2(21), RSMo, physicians who PUBLISHER’S NOTE: The secretary of state injured persons: have a pecuniary interest in physical therapy has determined that the publication of the 1. If the APRN is providing services or rehabilitation service facilities must dis- entire text of the material which is incorporat- pursuant to section 335.175, RSMo, no close that interest to patients who are pre- ed by reference as a portion of this rule would mileage limitation shall apply; scribed either physical therapy or rehabilita- be unduly cumbersome or expensive. This 2. If the APRN is not providing services tion services using the following form: material as incorporated by reference in this pursuant to section 335.175, RSMo, and is Missouri state law, 334.100.2(21), rule shall be maintained by the agency at its practicing the collaborating physician and col- RSMo, requires a physician notify the headquarters and shall be made available to laborating APRN shall practice within seven- patient or guardian that the physician the public for inspection and copying at no ty-five (75) miles by road of one another. has a pecuniary (financial) interest in the more than the actual cost of reproduction. 3. Pursuant to section 630.875, RSMo, This note applies only to the reference materi- an APRN collaborating with a physician who physical therapy facility in which pre- al. The entire text of the rule is printed here. is waiver-certified for the use of buprenor- scribed treatment is provided, and that phine, may participate in the “Improved physical therapy or rehabilitation ser- (1) For the purpose of these rules, the fol- Access to Treatment for Opioid Addictions vices are available to the patient on a lowing definitions shall apply: Program” (IATOAP) in any area of the state competitive basis from other facilities. (A) Advanced practice nurse—A registered and provide all services and functions of an professional nurse (RN) who is also an APRN. A remote collaborating physician Therefore, I understand that Dr.______advanced practice registered nurse (APRN) working with an on-site APRN shall be con- ______has a financial interest in as defined in section 335.016(2), RSMo; sidered to be on-site for the purposes of ______facility. (B) Controlled substance prescriptive IATOAP. authority—the eligibility and certificate (C) An APRN who desires to enter into a Further, I understand that I have the right to granted by the Missouri State Board of Nurs- collaborative practice arrangement at a loca- choose any other physical therapy or rehabili- ing (MSBN) to an APRN who has been del- tion where the collaborating physician is not tation services which may be more convenient egated the authority to prescribe controlled continuously present shall practice together at or competitive. substances from Schedules III, IV, and/or V the same location with the collaborating in a written collaborative practice arrange- physician continuously present for a period of ______ment by the collaborating physician as at least one (1) month before the collaborat- Patient/Guardian Signature defined in section 335.019, RSMo; ing APRN practices at a location where the (C) Collaborative practice arrangements— collaborating physician is not present. It is ______Refers to written agreements, jointly agreed the responsibility of the collaborating physi- Date upon protocols, or standing orders, all of cian to determine and document the comple- which shall be in writing, for the delivery of tion of the same location practice described in This should be retained in the patient’s per- health care services; the previous sentence. manent record. (D) Population-based ser- (D) A collaborating physician shall not vices—Health services provided to well enter into a collaborative practice arrange- AUTHORITY: sections 334.100.2(21), RSMo patients or to those with narrowly circum- ment with more than six (6) full-time equiva- Supp. 1990 and 334.125, RSMo 1986.* This scribed conditions in public health or lent APRNs, full-time equivalent physician rule originally filed as 4 CSR 150-5.030. community health settings that are limited to assistants, full-time equivalent assistant Original rule filed April 4, 1990, effective immunizations, well child care, human physicians, or any combination thereof. This Nov. 30, 1990. Moved to 20 CSR 2150-5.030, immunodeficiency virus (HIV) and sexually limitation shall not apply to collaborative effective Aug. 28, 2006. transmitted disease care, family planning, arrangements of hospital employees providing tuberculosis control, cancer and other chron- inpatient care service in as defined *Original authority: 334.100.2(21), RSMo 1939, amended 1945, 1959, 1963, 1974, 1976, 1979, 1981, 1983, 1984, ic disease, wellness screenings, services in Chapter 197, RSMo, or population-based 1986, 1987, 1989, 1990 and 334.125, RSMo 1959. related to epidemiologic investigations, and public health services as defined in this rule prenatal care; and or to a certified registered (E) Registered professional nurse—An RN providing services under the 20 CSR 2150-5.100 Collaborative Practice as defined in section 335.016(16), RSMo, supervision of an anesthesiologist or other Arrangement with Nurses who is not an APRN. physician, dentist, or who is imme- diately available if needed as set out in sec- PURPOSE: In accordance with section (2) Geographic Areas. tion 334.104(7), RSMo. 334.104, RSMo, this rule defines collabora- (A) The collaborating physician in a collab- tive practice arrangement terms and delimits orative practice arrangement shall not be so (3) Methods of Treatment. geographic areas; methods of treatment; geographically distanced from the collaborat- (A) The methods of treatment and the review of services; and drug/device dispens- ing RN or APRN as to create an impediment authority to administer, dispense, or prescribe ing or distribution pursuant to prescription to effective collaboration in the delivery of drugs delegated in a collaborative practice and implements the Utilization of health care services or the adequate review of arrangement between a collaborating physician by Nurses as required by section 335.175, those services. and collaborating APRN shall be within the RSMo and APRN involvement in the (B) The following shall apply in the use of scope of practice of each professional and “Improved Access to Treatment for Opioid a collaborative practice arrangement by an shall be consistent with each professional’s

JOHN R. ASHCROFT (6/30/21) CODE OF STATE REGULATIONS 9 Secretary of State 20 CSR 2150-5—DEPARTMENT OF COMMERCE AND INSURANCE Division 2150—State Board of Registration for the Healing Arts

skill, training, education, competence, licen- tions; inducing sedation or general anesthesia for sure, and/or certification and shall not be fur- 2. All labeling requirements outlined in therapeutic, diagnostic, or surgical proce- ther delegated to any person except that the section 338.059, RSMo, shall be followed; dures. When issuing the initial prescription individuals identified in sections 338.095 and 3. Consumer product safety laws and for an opioid controlled substance in treating 338.198, RSMo, may communicate prescrip- Class B container standards shall be followed a patient for acute , the APRN shall com- tion drug orders to a pharmacist. when packaging drugs for distribution; ply with requirements set forth in section (B) The methods of treatment and authori- 4. All drugs shall be stored according to 195.080, RSMo. Schedule II-hydrocodone ty to administer and dispense drugs delegated the Pharmacopeia (USP), and Schedule III narcotic controlled sub- in a collaborative practice arrangement (2010), published by the United States Phar- stance prescriptions shall be limited to a one between a collaborating physician and a col- macopeial Convention, 12601 Twinbrook hundred twenty- (120-) hour supply without laborating RN shall be within the scope of Parkway, Rockville, Maryland 20852-1790, refill. An APRN may prescribe buprenor- practice of each professional and shall be 800-227-8772; http://www.usp.org/ recom- phine, a Schedule III controlled substance, consistent with each professional’s skill, mended conditions, which is incorporated by for up to a thirty- (30-) day supply without training, education, and competence and reference. This does not include any later refill for patients receiving medication-assist- shall not be delegated to any other person amendments or additions; ed treatment for substance abuse disorders except the individuals identified in sections 5. Outdated drugs shall be separated under the direction of the collaborating physi- 338.095 and 338.198, RSMo, may communi- from the active inventory; cian as described in sections 334.104 and cate orders to a pharmacist. 6. Retrievable dispensing logs shall be 630.875, RSMo; (C) The collaborating physician shall con- maintained for all prescription drugs dis- 10. An APRN may not prescribe con- sider the level of skill, education, training, pensed and shall include all information trolled substances for his or her own self or and competence of the collaborating RN or required by state and federal statutes, rules, family. Family is defined as spouse, parents, APRN and ensure that the delegated respon- or regulations; grandparents, great-grandparents, children, sibilities contained in the collaborative prac- 7. All prescriptions shall conform to all grandchildren, great-grandchildren, brothers tice arrangement are consistent with that level applicable state and federal statutes, rules, or and sisters, aunts and uncles, nephews and of skill, education, training, and competence. regulations and shall include the name, nieces, mother-in-law, father-in-law, broth- (D) Guidelines for consultation and referral address, and telephone number of the collab- ers-in-law, sisters-in-law, daughters-in-law, to the collaborating physician or designated orating physician and collaborating APRN; and sons-in-law. Adopted and step members health care facility for services or emergency 8. An RN shall not, under any circum- are also included in family; care that is beyond the education, training, stances, prescribe drugs. The administering 11. An APRN or RN in a collaborative competence, or scope of practice of the col- or dispensing of a controlled substance by an practice arrangement may only dispense laborating RN or APRN shall be established RN or APRN who has not been delegated starter doses of medication to cover a period in the collaborative practice arrangement. authority to prescribe in a collaborative prac- of time for seventy-two (72) hours or less (E) The methods of treatment, including tice arrangement, pursuant to 19 CSR 30- with the exception of Title X family planning any authority to administer or dispense 1.066, shall be accomplished only under the providers or publicly funded clinics in com- drugs, delegated in a collaborative practice direction and supervision of the collaborating munity health settings that dispense medica- arrangement between a collaborating physi- physician, or other physician designated in tions free of charge. The dispensing of drug cian and a collaborating RN shall be deliv- the collaborative practice arrangement, and samples, as defined in 21 U.S.C. section ered only pursuant to a written agreement, shall only occur on a case-by-case determina- 353(c)(1), is permitted as appropriate to com- jointly agreed-upon protocols, or standing tion of the patient’s needs following verbal plete drug therapy; orders that shall describe a specific sequence consultation between the collaborating physi- 12. The collaborative practice arrange- of orders, steps, or procedures to be followed cian and collaborating RN or APRN. The ment shall clearly identify the controlled sub- in providing patient care in specified clinical required consultation and the physician’s stances the collaborating physician authorizes situations. directions for the administering or dispensing the collaborating APRN to prescribe and doc- (F) The methods of treatment, including of controlled substances shall be recorded in ument that it is consistent with each profes- any authority to administer, dispense, or pre- the patient’s chart and in the appropriate dis- sional’s education, knowledge, skill, and scribe drugs, delegated in a collaborative pensing log. These recordings shall be made competence; and practice arrangement between a collaborating by the collaborating RN or APRN and shall 13. The medications to be administered, physician and a collaborating APRN shall be be cosigned by the collaborating physician dispensed, or prescribed by a collaborating delivered only pursuant to a written agree- following a review of the records; RN or APRN in a collaborative practice ment, jointly agreed-upon protocols, or 9. In addition to administering and dis- arrangement shall be consistent with the edu- standing orders that are specific to the clini- pensing controlled substances, an APRN, as cation, training, competence, and scopes of cal conditions treated by the collaborating defined in section 335.016, RSMo, may be practice of the collaborating physician and physician and collaborating APRN. delegated the authority to prescribe controlled collaborating RN or APRN. (G) Methods of treatment delegated and substances listed in Schedule II-hydrocodone (H) When a collaborative practice arrange- authority to administer, dispense, or pre- and Schedules III, IV, and V of section ment is utilized to provide health care services scribe drugs shall be subject to the following: 195.017, RSMo in a written collaborative for conditions other than acute self-limited or 1. The physician retains the responsibil- practice arrangement, except that, the collab- well-defined problems, the collaborating ity for ensuring the appropriate administer- orative practice arrangement shall not dele- physician, or other physician designated in the ing, dispensing, prescribing, and control of gate the authority to administer any con- collaborative practice arrangement, shall drugs utilized pursuant to a collaborative trolled substances listed in Schedule examine and evaluate the patient and approve practice arrangement in accordance with all II-hydrocodone and Schedules III, IV, and V or formulate the plan of treatment for new or state and federal statutes, rules, or regula- of section 195.017, RSMo, for the purpose of significantly changed conditions as soon as is

10 CODE OF STATE REGULATIONS (6/30/21) JOHN R. ASHCROFT Secretary of State Chapter 5—General Rules 20 CSR 2150-5

practical, but in no case more than two (2) stances and also report to the board the name patient’s or the patient’s guardian’s consent weeks after the patient has been seen by the of each licensed RN or APRN with whom in the patient’s file or chart. All telehealth collaborating APRN or RN. If the APRN is he/she has entered into such agreement. A activities must comply with the requirements providing services pursuant to section change shall include, but not be limited to, of the Health Insurance Portability and 335.175, RSMo, the collaborating physician, resignation or termination of the RN or Accountability Act of 1996 and all other or other physician designated in the collabora- APRN; change in practice locations; and applicable state and federal laws and regula- tive practice arrangement, may conduct the addition of new collaborating professionals. tions. examination and evaluation required by this (D) An RN or an APRN practicing pur- (G) The collaborating physician and col- section via live, interactive video or in person. suant to a collaborative practice arrangement laborating RN or APRN shall determine an Telehealth providers shall obtain the patient’s shall maintain adequate and complete patient appropriate process of review and manage- or the patient’s guardian’s consent before records in compliance with section 334.097, ment of abnormal test results which shall be telehealth services are initiated and shall doc- RSMo. documented in the collaborative practice ument the patient’s or the patient’s guardian’s (E) The collaborating physician shall com- arrangement. consent in the patient’s file or chart. All tele- plete a review of a minimum of ten percent (H) The Missouri State Board of Registra- health activities must comply with the (10%) of the total health care services deliv- tion for the Healing Arts and the Missouri requirements of the Health Insurance Porta- ered by the collaborating APRN. If the State Board of Nursing separately retain the bility and Accountability Act of 1996 and all APRN’s practice includes the prescribing of right and duty to discipline their respective other applicable state and federal laws and controlled substances, the physician shall licensees for violations of any state or feder- regulations. review a minimum of twenty percent (20%) al statutes, rules, or regulations regardless of (I) Nothing in these rules shall be con- of the cases in which the APRN wrote a pre- the licensee’s participation in a collaborative strued to permit medical diagnosis of any scription for a controlled substance. If the practice arrangement. condition by an RN pursuant to a collabora- controlled substance chart review meets the tive practice arrangement. minimum total ten percent (10%) as (5) Population-Based Public Health Services. described above, then the minimum review (A) In the case of the collaborating physi- (4) Review of Services. requirements have been met. The collaborat- cians and collaborating registered - (A) In order to assure true collaborative ing APRN’s documentation shall be submit- al nurses or APRN practicing in association practice and to foster effective communication ted for review to the collaborating physician with public health clinics that provide popu- and review of services, the collaborating at least every fourteen (14) days. This docu- lation-based health services as defined in sec- physician, or other physician designated in mentation submission may be accomplished tion (1) of this rule, the geographic areas, the collaborative practice arrangement, shall in person or by other electronic means and methods of treatment, and review of services be immediately available for consultation to reviewed by the collaborating physician. The shall occur as set forth in the collaborative the collaborating RN or APRN at all times, collaborating physician must produce evi- practice arrangement. If the services provid- either personally or via telecommunications. dence of the chart review upon request of the ed in such settings include diagnosis and ini- (B) The collaborative practice arrangement Missouri State Board of Registration for the tiation of treatment of disease or not between a collaborating physician and a col- Healing Arts. This subsection shall not apply related to population-based health services, laborating RN or APRN shall be signed and during the time the collaborating physician then the provisions of sections (2), (3), and dated by the collaborating physician and col- and collaborating APRN are practicing (4) above shall apply. laborating RN or APRN before it is imple- together as required in subsection (2)(C) mented, signifying that both are aware of its above. AUTHORITY: sections 334.125 and 335.175, content and agree to follow the terms of the (F) If a collaborative practice arrangement RSMo 2016, and sections 334.104.3 and collaborative practice arrangement. The col- is used in clinical situations where a collabo- 335.036, RSMo Supp. 2018.* This rule orig- laborative practice arrangement and any sub- rating APRN provides health care services inally filed as 4 CSR 150-5.100. Original rule sequent notice of termination of the collabo- that include the diagnosis and initiation of filed Jan. 29, 1996, effective Sept. 30, 1996. rative practice arrangement shall be in treatment for acutely or chronically ill or Amended: Filed April 1, 1998, effective Oct. writing and shall be maintained by the col- injured persons, then the collaborating physi- 30, 1998. Amended: Filed Oct. 30, 2002, laborating professionals for a minimum of cian shall be present for sufficient periods of effective June 30, 2003. Moved to 20 CSR eight (8) years after termination of the col- time, at least once every two (2) weeks, except 2150-5.100, effective Aug. 28, 2006. Amend- laborative practice arrangement. The collabo- in extraordinary circumstances that shall be ed: Filed Dec. 14, 2007, effective June 30, rative practice arrangement shall be reviewed documented, to participate in such review and 2008. Rescinded and readopted: Filed April at least annually and revised as needed by the to provide necessary medical direction, medi- 30, 2010, effective Nov. 30, 2010. Amended: collaborating physician and collaborating RN cal services, consultations, and supervision of Filed Nov. 14, 2014, effective June 30, 2015. or APRN. Documentation of the annual the health care staff. In such settings, the use Emergency amendment filed April 16, 2018, review shall be maintained as part of the col- of a collaborative practice arrangement shall effective April 26, 2018, expired Feb. 5, 2019. laborative practice arrangement. be limited to only an APRN. If the APRN is Amended: Filed April 16, 2018, effective Oct. (C) Within thirty (30) days of any change providing services pursuant to section 30, 2018. Emergency amendment filed Feb. and with each physician’s license renewal, the 335.175, RSMo, the collaborating physician 22, 2019, effective March 4, 2019, expired collaborating physician shall advise the Mis- may be present in person or the collaboration Aug. 30, 2019. Amended: Filed Feb. 22, souri State Board of Registration for the may occur via telehealth in order to meet the 2019, effective Aug. 30, 2019. ** Healing Arts whether he/she is engaged in requirements of this section. Telehealth any collaborative practice agreement, includ- providers shall obtain the patient’s or the *Original authority: 334.104.3, RSMo 1993 amended 2002, 2003, 2006, 2008, 2009, 2012, 2013, 2015, 2018; ing collaborative practice agreements delegat- patient’s guardian’s consent before telehealth 334.125, RSMo 1959, amended 1993, 1995, 2014; ing the authority to prescribe controlled sub- services are initiated and shall document the 335.036, RSMo 1975, amended 1981, 1985, 1993, 1995,

JOHN R. ASHCROFT (9/30/21) CODE OF STATE REGULATIONS 11 Secretary of State 20 CSR 2150-5—DEPARTMENT OF COMMERCE AND INSURANCE Division 2150—State Board of Registration for the Healing Arts

1999, 2007, 2008, 2011, 2018; and 335.175, RSMo 2013, 2016.

**Pursuant to Executive Order 21-07, 20 CSR 2150-5.100, subsec- tion (2)(B) was suspended from March 26, 2020 through August 31, 2021 and subsections (2)(C) and (4)(E) was suspended from April 2, 2020 through August 31, 2021.

12 CODE OF STATE REGULATIONS (9/30/21) JOHN R. ASHCROFT Secretary of State