department of regulatory agencies
Division of Professions and Occupations
3 CCR 716-1
CHAPTER 24
RULES AND REGULATIONS
CONCERNING RESPONSIBILITIES OF ADVANCED PRACTICE REGISTERED NURSESWITH PRESCRIPTIVE AUTHORITY WHO ENGAGE IN DRUG THERAPY MANAGEMENT WITH A COLORADO LICENSED PHARMACIST
BASIS: The authority for the promulgation of these rules and regulations by the State Board of Nursing (“Board”) is set forth in Sections 12-38-108(1)(j) and 12-38-111.6 of the Colorado Revised Statutes (C.R.S.).
PURPOSE: The Board has adopted these Rules to authorizeadvanced practice registered nurses with prescriptive authority to participate with qualified pharmacists in drug therapy management, in conjunction and consistent with the Colorado State Board of Pharmacy; and to delineate the requirements and responsibilities applicable to an advanced practice registered nurse with prescriptive authority who enters into an agreement with a Colorado licensed pharmacist to provide “drug therapy management” by protocol as defined in these Rules. The Colorado State Board of Pharmacy Rule 6.00.00 (“Pharmaceutical Care, Drug Therapy Management and Practice by Protocol”) defines the requirements and responsibilities applicable to a Colorado licensed pharmacist who enters into an agreement with a Colorado licensed prescriber to provide “drug therapy management” by protocol.
RULES AND REGULATIONS
1.DEFINITIONS: For the purposes of these Chapter 24 rules, the following terms have the indicated meaning:
1.1“Active, unrestricted license” means a license that is not currently subject to any practice restrictions, encumbrances, terms, or conditions including, but not limited to terms of probation.
1.2“Board” means the State Board of Nursing unless otherwise specified in these Rules.
1.3“Drug therapy management” or “DTM” means the review and evaluation of drug therapy regimens for patients undertaken by a pharmacist in order to provide drug therapy, monitorprogress and modify drug therapy. Drug therapy management may only be undertaken pursuant to an initial diagnosis made by an advanced practice nurse with full prescriptive authority (RXN), a valid order for the therapy, and a written agreement, which delineates proper protocols to be used, and the type of interaction that must occur between the pharmacist and the RXN.
1.3.1Drug therapy management may include:
1.3.1.1 Collecting and reviewing patient drug histories;
1.3.1.2 Obtaining and checking vital signs;
1.3.1.3 Ordering and evaluating the results of laboratory tests directly related to management of the drug therapy when performed in compliance with the protocol ordered by the RXN;
1.3.1.4 Modifying drug therapywhen appropriate,incompliancewiththe protocolordered bytheRXN;and
1.3.1.5 Implementing thedrug therapyplan agreed upon between the RXNand thepharmacist,using a protocoland managing thetherapy according tothe protocol.
1.4“Protocol” meansaspecificwritten plan for acourse oftreatmentfora certain disease state containing awritten setofspecificdirectionscreatedbytheRXN.
1.5“RXN” means, for purposes of these Chapter 24 rules, an advanced practice registered nurse with an active, unrestricted license having full prescriptive authority in Colorado.
2.ELIGIBILITYTOENTERINTOADRUG THERAPYMANAGEMENTAGREEMENT:
2.1An RXNmayengagein drug therapymanagementbyprotocolwitha Coloradolicensed pharmacistonlywhenthe protocolused iswithin thescopeoftheRXN’s current practiceand is consistentwith theRXN’s role and population focus.
2.2Onlyan RXN with anactive,unrestricted license as defined herein and having full prescriptive authority in Coloradomayengagein adrug therapy managementagreement with a Coloradolicensed pharmacist. Upona showing ofgoodcauseand written request,theBoardmayallowan RXNwitha restricted or an encumbered licenseto engagein drug therapy managementwith a Coloradolicensed pharmacist. Consideration maybegivenon a case bycasebasis. Itis anticipated thatsuchwaivers would berare. The decisiontograntsucha waiver shallbein thesole discretion ofthe Board.
2.3An RXNmay engagein a drug therapymanagementagreementonlywith a Coloradolicensed pharmacistwhohasan active,unrestricted licenseto practice pharmacyandwhomeetsthe qualificationstoprovidedrug therapymanagementas determined bytheColoradoStateBoardofPharmacyand setforth inPharmacy BoardRule6.00.30.
3.PROTOCOL REQUIREMENTS:
3.1Theprotocolused byan RXN and pharmacistengaging in drug therapymanagement mustfollow theformatof and contain the elementsrequiredby Section 6 of these rules.
3.2Theprotocol used byanRXN and pharmacistengaging in drug therapymanagement must demonstratea planoftreatmentthatconstitutesevidence-basedpractice. This meansthattheplanof treatmentmustbeguidedby orbasedon current,objective,and supportedscientificevidenceas published in scientificliterature,rather than anecdotal observations.
3.3Theprotocol shall besigned and dated bytheauthorizing RXN. Uponrequest,theRXN shallsubmitthewritten protocolsfor drug therapy managementtotheBoardfor review.
3.4Theprotocolshall bereviewed and revised asnecessarybytheRXN,and at least annually. The protocolmustalsoberevised in a timelyfashion toreflectany changesin theaccepted standard of care.
3.5Theprotocol developedmustallowforthe provision of patientcarethatmeets generallyaccepted standards ofpractice.
4.REQUIREMENTS FOR WRITTEN AGREEMENTS OR GENERAL AUTHORIZATION PLANS:
4.1If applicable, RXNs who wish to engage in drug therapy management with Colorado licensed pharmacists in an inpatient setting or in a group model integrated closed HMO setting must first execute a general authorization plan. The general authorization plan must identify those RXNs, other prescribing healthcare providers, and pharmacists who are authorized and who have agreed to participate in drug therapy management in the specified practice setting. The general authorization plans must define the responsibilities of the RXNs, the other prescribing healthcare providers, and pharmacists engaging in drug therapy management in order to assure compliance with generally accepted standards of practice and with those items set forth in Section 4.2 of these Rules.
4.2AnRXN whowishes toengagein drug therapymanagement byprotocolwith a Colorado licensed pharmacistin any other setting mustfirstexecuteawritten agreement containingthefollowing information:
4.2.1Pharmacist’sname and license number;
4.2.2RXN’s name and RXN identifier number;
4.2.3Diagnosesrelevanttothedrug therapytobemanaged and otherpatient conditionsrelevantto maintenanceof the patient’shealth during drug therapy management;
4.2.4Protocolto beemployed;
4.2.5Functionsand activitiesthepharmacistwill perform,and restrictions orlimitationson the pharmacist’smanagement;
4.2.6Method,contentand frequencyof reportstotheRXN;
4.2.7Manner inwhich pharmacist’sdrug therapymanagementwillbe monitored bytheRXN, including method and frequency;
4.2.8A specifiedtime,nottoexceed 24hours(excluding Saturdays,Sundaysand Stateholidays),within which thepharmacistmust notifytheRXNorwhen applicable,acoveringRXN or covering physician, ofany modificationsof drug therapy;
4.2.9Within 72hoursfollowing notification bythe pharmacist,theRXNmust reviewand document acceptanceor rejectionofthedrug therapy modification;
4.2.10A provision thatallowstheRXNto overrideanyaction taken bythe pharmacistwhenthe RXNdeemsittobe necessary;
4,2,11An effectivedateof theagreementand signaturesof both parties;
4.2.12Aprovision addressinghowdrug therapymanagementwill be handled whenthepatienthasmore than oneprescribing healthcare provider involved in evaluatingortreatingthemedical conditionwhichis thesubjectofthe agreement. All prescribing healthcare providerswhoareactivelyinvolved in themanagementoftherelevantconditionsshall bepartiestotheagreement; and
4.2.13A provision thatthepharmacistagreestomaintain liabilityinsurancein theamountofatleast$1,000,000peroccurrence.
4.3Anygeneral authorization plan orwritten agreement executed in accordancewith theseRulesmust allowanyRXN, other prescribing healthcare provider,orpharmacist towithdrawfromthegeneralauthorization plan orwritten agreementwithin a periodof timespecified in theagreement.
5.RECORDKEEPING AND RETENTIONOF RECORDS
5.1AnRXNwhoengagesin drug therapymanagementbyprotocolwith a Coloradolicensed pharmacistmustobtain copies ofthepharmacist’srecordsforeach patientin atimely manner andmust reviewsuch records.
5.2TheRXN’sreceiptand reviewof therecordsareimportantforthefollowing reasons:
5.2.1toassurethatthe drug therapymanagementisin compliancewith the protocol and with theseRules;
5.2.2toassurethattheRXN’sdecision toparticipatein drug therapymanagementis consistentwith generallyaccepted standards ofpractice;
5.2.3toassurethatthe patient’sdrug therapymanagementrecordsarecomplete;and
5.2.4toassurethattheRXN is providing overallcaretothepatientthatmeets generallyaccepted standards ofpractice.
6.ELEMENTS TOBE INCLUDED IN THE PROTOCOL DEVELOPEDANDUSEDFORDRUG THERAPY MANAGEMENTBYANRXNAND PHARMACISTS
6.1For the purposes ofdrug therapymanagement(DTM),theprotocolmustcontainall of theinformation required byBoardofPharmacyRule6,3CCR719-1,and Sections 3 and6ofthisBoard of Nursing Chapter 24 Rule.
6.2In addition,a protocol created for drug therapymanagementbyan RXNworking with pharmacists should adoptthefollowingformat:
6.2.1Diseasestatebeing addressed.
6.2.2Setting forapplicationof DTM.
6.2.3Goal ofthe useof theprotocolforthe diseasestate(limitthedegradation, maintain thestatus, and/or improvethecondition ofpatientswith the diseasestate).
6.2.4Summaryof whowilldowhatwithin the respective scopes of practice (whatthe RXNwill do,whatthepharmacistwill do).
6.2.5.Indicatehow patientsmaygetreferred intothisdiseasestate program (forexample,froman RXN practicing within their role and population focus, internist,family physicianor cardiologist).
6.2.6Indicatetheenrollmentcriteria forthis diseasestate(for example,a historyof myocardial infarction, percutaneoustransluminalangioplastyorstent placement,etc.).
6.2.7Indicateanyotherdiseasestatesthatmay bepresentand theappropriate attention tothosestates during treatmentforthis diseasestate. If thereare anyimplicationsforthistreatment,specifyhow thoseimplicationswill be handled.
6.2.8Specifythe natureand scopeofthetherapyto beundertaken,thespecific directionsforeach drug to beused,thespecified dosageregimen,formsor route of administration,directionsfor implementingand monitoring thetherapy, identificationofappropriateteststhatmayberequested and forwhat purposes, delineating critical test values and specificparametersfor dosagemodification. If a laboratory monitoring protocol is notindividuallydeveloped,indicatethe clinicalparametersof laboratory monitoring for thediseasestateforeach protocol. Thespecificityrequired abovemaybe portrayedvia an algorithmor similarmatrixif thediseasestatelendsitself tosuch definition.
6.2.9Specifyother interventionsnecessaryfor therapy(for example,lipid lowering therapy,aspirin therapyor non-pharmacologictreatment necessarysuch as diet,physical activity,alcoholuse,tobacco cessation,etc.). Indicatewhether or notthoseinterventionsarewithin theDTMagreement,and if so, repeat the information in 6.2.8 of this Chapter 24 rule for those states. Specifyany mitigating factors thatmayapplytothetherapy.
6.2.10Specifyclinical exclusions or aggravating factors. Thatis,ifthereareknown situationswherea patientshould not participateinDTMor whose participation should belimited insomeway. Specify howthis will be addressed.
6.2.11Indicatespecificdirectionsfor responding toacuteallergicorother adverse reactionstotherapyand themethod whereby patientsafetywill bepreserved and safeguarded in such asituation.
6.2.12Indicatetrackingmechanismstobeusedtoensuretimeliness oftherapyand patientvisits,and the methodof follow-up if thepatientdoesnotmakevisits; specifymethodof qualityassurancecheckson this.
6.2.13Indicatethereporting required bythepharmacistand theRXN.
6.2.14Indicatethereferencestotheevidencebasedarticle(s)thatsupportthe protocol being used.
6.3Signatures. Personsresponsiblefordrug therapymanagementmustsign the protocol,to indicatethattheyhave read themand understandthescopeoftheir responsibilities. In anyevent,theRXN, pharmacist, and all prescribing healthcare providers who are actively involved in the DTM shall be held responsibleforthetherapy. DTMmay not be delegated bythe RXN, unless it is to and withina prescribing healthcare provider’s scope of practice, and onlyaftertheRXNhasmadea diagnosis and referred the patient totherapy.
Adopted:October 27, 2015
Effective:December 30, 2015