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    PHARMACOTHERAPY Volume 31, Number 8, 2011

    In 2000, the Society of Critical Care Medicine(SCCM) and the American College of ClinicalPharmacy (ACCP) published a position paperthat defined the scope of critical care pharmacyservices.1 This report encompasses clinical andnonclinical pharmacy services and stratifies levels

    of service as fundamental, desirable, or optimalto patient care. Fundamental activities reflectser vices asso ciated with o r der en tr y an ddistribution duties that are necessary for the safeprovision of pharmaceutical care; desirableactivities add some clinical functions necessaryfor the specialized care of critically ill patients;an d optimal activities reflect an integrated,specialized, and dedicated model of direct patientcare functions that aim to maximize outcomes.Various aspects of pharmacy practice areaddressed in this report including clinical,

    educational, administrative, and scholarly

    activities. The results of a recent survey foundthat fundamental services are consistentlyprovided to the intensive care unit (ICU) butdesirable or optimal services are far less likely tooccur across all types of practice activities.2

    The provision of fundamental services to ICU

    patients is key to insure safe patient care.However, technological advances (e.g., provider-order entry, integrated profiles, automateddistribution systems, bar coding, etc.) and policychanges (e.g., technician-check-technician) mayshift responsibilities to possibly render the role oralter the manner in which pharmacists providethese services. Concurrently, competitivepressures and safety mandates are drivinginstitutions to focus resources on specificservices, including the care and outcomes of thecritically ill.3 Several initiatives (e.g., ability and

    practice-based outcomes of the AccreditationCouncil of Pharmacy Education (ACPE),medication therapy management services,Medicare amendments recognizing pharmacistsa s p ro v id e rs , t he J o in t C om mi ss i on o nAccreditation of Healthcare Organizations(JCAHO; now termed The Joint Commissionor TJC) national patient safety goals)3-5 areempowering pharmacists to practice higher levelpharmacotherapy that necessitates direct patientcare. Th e J o int C o mmission o f P h ar macyPractitioners envisions that pharmacists will

    have the authority and autonomy to managemedication therapy and will be accountable forpatients therapeutic outcomes.6 To achieve anoptimal model of patient care in the ICU, SCCMrecommends a collaborative approach to ICUc are w it h a n e mp ha si s o n p ra ct it io ne rcertification.7, 8 Pharmacy organizations havecollaboratively indicated that pharmacists willrequire credentials in the future to providevarious levels of patient care services.9

    In order to meet the growing demands ofproviding, documenting, and justifying pharmacy

    services in the ICU, a task force was convened todevelop an opinion paper addressing these issues.The task force included individuals who aremembers of the ACCP critical care practice andresearch network (PRN), the SCCM clinicalpharmacy and pharmacology (CPP) section, andAmerican Society of Health-System Pharmacists(ASHP). The specific objectives of the task forcewere to: 1) provide recommendations for thelevel of preparation and training of pharmacistst o p ra c ti ce i n c ri t ic al c ar e, 2 ) d ev e lo precommendations for the credentialing ofpharmacists providing critical care services, and

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    For questions or comments, contact Robert MacLaren,Pharm.D., FCCM, FCCP, Department of Clinical Pharmacy,University of Colorado School of Pharmacy, 12850Montview Blvd, V20-1227, Aurora, CO 80045; e-mail:[email protected].

    Opinions expressed in this document are endorsed by theAmerican College of Clinical Pharmacy critical care practiceand research network, the Society of Critical Care Medicineclinical pharmacy and pharmacology section, and theAmerican Society of Health-System Pharmacists.

    Writing committees:Training Pharmacists: William Dager, Pharm.D. (University

    of California Davis Medical Center, Davis, CA) (chair); ScottBolesta, Pharm.D. (Wilkes University, Wilkes Barre, PA);Gretchen Brophy, Pharm.D. (Virginia CommonwealthUniversity, Richmond, VA); Kamila Dell, Pharm.D.(University of Utah Hospital and Clinics, Salt Lake City,UT); Anthony Gerlach, Pharm.D. (Ohio State UniversityMedical Center, Columbus, OH); Judith Kristeller, Pharm.D.(Wilkes University, Wilkes Barre, PA); Scott Micek,Pharm.D. (Barnes Jewish Hospital, St. Louis, PA).Credentialing Pharmacists: Mary Hess, Pharm.D. (JeffersonUniversity, Philadelphia, PA) (chair), Michael Bentley,Pharm.D. (Carilion Clinic - Roanoke Memorial Hospital,Roanoke, VA); Paul Juang, Pharm.D. (St. Louis College ofPharmacy, St. Louis, MO).Documenting and Justifying Services: Robert MacLaren,

    Pharm.D. (University of Colorado, Aurora, CO) (chair);Sandra Kane-Gill, Pharm.D. (University of Pittsburgh,Pittsburgh, PA); Krystal Haase, Pharm.D. (Texas TechUniversity, Amaril lo, TX); Henry Mann, Pharm.D.(University of Toronto, Toronto, ON); Colby Miller,Pharm.D. (LifeBridge Health, Baltimore, MD); Diane Pepe,Pharm.D. (The Medical Center of Aurora, Aurora, CO);Robin Southwood, Pharm.D. (University of Georgia,Athens, GA); Kyle Weant, Pharm.D. (University of Kentucky, Lexington, KY).Steering / Editing committee:

    William Dager, Mary Hess, Robert MacLaren (chair), JillRebuck, Pharm.D. (Lancaster General Hospital, Lancaster,PA); Christopher Wood, Pharm.D. (University of Tennessee,Memphis, TN).

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    3) develop mechanisms for documenting andjustifying ICU pharmacy services. Thisdocument was developed over a two year periodwith subcommittees assigned to each objective.The subcommittees communicated electronicallya nd c on ve ne d s ev er al t im es a t v ar io us

    professional conferences. Integration andalignment of the three sections was completed bya steering / editing committee comprised of thechairs of each subcommittee and the chairs of theACCP critical care PRN and the SCCM CPP.

    Each objective was addressed to accommodatethe levels of services defined as fundamental,desirable, or optimal and are targeted at allpharmacists providing or wanting to providepharmacy services to critically ill patients. Therecommendations, however, are focused ondelivering direct and proactive patient care

    services at the desirable and optimal levels withthe ultimate goal of enhancing the level ofpharmacy services provided to the care ofcritically ill patients. Recommendations weredeveloped according to realistic standardsalthough idealistic or speculative expectationswere also addressed. These recommendationsapply to all ICU practice sites and populations(e.g., medical, surgical, neurosurgical, trauma,burn, pediatric, neonatal, etc.) or any siteencountering ICU patients (e.g., transplant,operating room, emergency room, etc.) across all

    types of institutions (community, private,academic, government, etc.) of all sizes providingall levels of medical care (level I III).7 Therecommendations are dynamic so that theindividual pharmacist, the department ofpharmacy, or hospital administration maydevelop, enhance, and maximize their services.Additionally, this document should be of greatinterest to the pharmacy department, other ICUhealthcare professionals, hospital and academicadministrators, accrediting agencies, governmentofficials, payers, and patients or their families.

    Requirements of the ICU Pharmacist

    The genesis of the ICU pharmacist typicallybegins with an individual entering or desiring toexpand their practice by developing skill sets thatallow practice advancements or transitions tohigher level activities relative to the care ofcritically ill patients. Including pharmacists inthe care of critically ill patients can lead tosuperior care by utilizing their role as the ICUpharmacotherapy knowledge manager.7, 8, 1013

    To be successful in such a role, pharmacists need

    a strong knowledge base and diverse skill setsthat include effective communication, advancedproblem solving / critical thinking, judgment,leadership, and time management. These skillsare optimized when pharmacy services aredirectly provided in a proactive and applied

    manner. Of note, ACCP recently published anopinion paper describing the competenciesre qu ire d b y c li ni ca l p ha rm ac is ts t ha tindependently recommended skill sets similar tothose put forth in this paper.14

    Pharmacotherapy manager

    ICU pharmacists must integrate pharmacology,ph ar maco kin etics / ph ar maco dyn amics / pharmacogenomics, pharmacoeconomics, andpharmacotherapeutics with pathophysiological

    changes in the management of critical illness.

    10,

    1517 Table 1 summarizes examples of coretherapeutic topics that pharmacists providingcare to adult ICU patients with these diseases ordisorders should be knowledgeable of to thee x t e n t t h a t t h e y a r e a b l e t o b e t h e I C Upharmacotherapy manager.12 Additional coretopics may apply to pharmacists providingservices to specialized patient populations (e.g.,pediatric, neonatal, burn, transplant, emergencymedicine, etc.). All pharmacists should maintaina knowledge base that incorporates currentmedical advances reported in the literatureincluding any associated controversies in a givensituation.1 Knowledge must be integrated withsound judgment and the skill of practicalapplication. This requires clinical familiarity andexperience. A commitment to life-long learning,skill development, and resource development isessential to continually delivering any level ofpharmacy service.

    ICU pharmacists must possess statisticalknowledge to the extent that they are able tointerpret and apply data to patient-specificscenarios. Pharmacists providing desirable or

    optimal levels of care must understand andin tegr ate n o n dr u g in ter ven tio n s su ch asmechanical devices (e.g., ventilators, renalreplacement therapies, vascular catheterization,point-of-care testing, etc.), procedural processes(e.g., paracentesis; thorocostomy; basic surgicalinterventions; interventional radiology; fiberopticimaging such as bronchoscopy or endoscopy;radiographic imaging such as computerizedtomography, magnetic resonance imaging,fluoroscopy, radiography, etc.), measuredr es po n se s ( e .g . , b e ds i de o b se r va t io n s;

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    Table 1. Examples of Core Therapeutic Topics for Pharmacists Caring for Critically Ill Adults.

    Therapeutic Area Specific Disease State, Condition, or Device

    Neurology and Psychiatry Altered mental status, encephalopathy, comaBrain injuryCerebrovascular diseases (e.g., hemorrhage, ischemia, thromboembolic)DeliriumEncephalopthyIntracranial perfusionMovement disorders (e.g. neuroleptic malignant syndrome, seratonin syndrome, malignant

    hyperthermia, dystonia / dyskinesia, botulism, tetanus, etc)Neuromuscular blockadeNeuromuscular diseases (e.g., Guillain-Barre syndrome, myasthenia gravis, etc.)Neuropathies, myopathiesPain managementSedation managementSeizure management and prophylaxisSubstance abuseSpinal cord injury

    Withdrawal syndromes (e.g., alcohol, opiate, nicotine, etc.)

    Cardiovascular Acute coronary syndromes (unstable angina, myocardial infarction)Acute heart failure (right and left sided, diastolic and systolic)

    Anaphylactic shockAortic aneurysmAortic dissectionArrhythmias (atrial fibrillation and flutter, paroxysmal supraventricular tachycardia, ventricular

    tachycardia and fibrillation, QT prolongation, sinus bradycardia, atrioventricular bradycardia,pulseless electrical activity, asystole)

    Cardiac temponadeCardiac or vascular surgical proceduresCardiopulmonary resuscitationCardiovascular shockCardiac ArrhythmiasHypovolemic shockHypertensive emergencies and urgenciesMechanical assist devicesMyocardial contusionPericarditisPeripheral arterial occlusionValvular diseasesVenous thromboembolism management and prophylaxis

    Pulmonary Acute respiratory distress syndromeAsthmaAspirationChronic obstructive pulmonary diseasesCystic fibrosisEtiologies of hemoptysisExtracorporeal membrane oxygenationInhalation injuryMechanical ventilationNear drowning

    Obesity hypoventilation syndromePleural effusionsPulmonary arterial hypertensionPneumothorax, hemothoraxPulmonary embolism and other embolic syndromesSurgical resections

    Hepato-gastrointestinal Acute abdomen and necrosisAscitesCholycystitisFulminant hepatic failureHepato-renal syndromeLower gastrointestinal hemorrhageMotility disorders (e.g., ileus, gastroparesis, etc.)Malabsorptive disorders (e.g., inflammatory bowel disease, short bowel syndrome, etc.)

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    Table 1. (continued)

    Therapeutic Area Specific Disease State, Condition, or Device

    Hepato-gastrointestinal Nonvariceal upper gastrointestinal hemorrhagePancreatitisMesenteric or splanchnic thrombosisStress-related mucosal diseaseVariceal hemorrhageViral hepatitis

    Renal Acute kidney injury (prerenal, intrinsic, postrenal)Fluid and electrolytes homeostasis, abnormalities, and replacementPrevention of renal dysfunctionQuantification of renal functionRenal replacement therapiesRhabdomyolysis

    Hematology AnemiasCoagulopathyHemorrhagic shockHemolytic uremic syndromeHematologic neoplasmsHypercoagulation disordersNeutropeniaSickle cell crisisThrombocytopeniaThrombotic thrombocytopenic purpuraTransfusion medicine

    Endocrine Adrenal insufficiencyAlcoholic ketoacidosisAutoimmune disorders (e.g., lupus, sarcoides, rheumatic disease, vasculitis, etc.)Cushings syndromeDiabetic ketoacidosis, hyperosmotic nonketoacidosisGlucose controlHypothyroidism, myxedema comaPheochromocytomaThyrotoxicosisTumor lysis syndrome

    Infectious Diseases Bloodstream and line infectionsBone and joint infectionsCentral nervous system infections (meningitis, encephalitis, abscess, shunt infection)EndocarditisGastrointestinal infections (e.g., E. coli hemorrhagic diarrhea, C. difficile diarrhea, Travelers

    diarrhea, Yersinia, viral diarrhea, etc)Institution-specific antimicrobial susceptibility patternsIntra-abdominal infections (e.g., abscess, peritonitis, cholycystitis, etc.)Opportunistic infections (fungal, viral, bacterial, parasitic, etc.)Oropharynx (Ludwigs angina, epiglottitis, pharyngeal space, peritonsillar or laryngeal abscess)Pneumonia (community-acquired, nosocomial, ventilator-associated, aspiration)Sepsis, severe sepsis, and septic shockSinusitisSkin and soft tissue infections (e.g., cellulitis, necrotization, diabetic, etc.)

    Spontaneous bacterial peritonitisSurgical prophylaxis and wound infectionsTuberculosisUrinary tract infections (e.g., pyelonephritis, catheter-related, etc.)

    Other Acid / base disordersAdverse drug eventsBiohazard exposureBioterrorism exposureDermatology (e.g., decubitus ulcer, toxic epidermal necrolysis, erythema multiforme, necrosis, etc.)Drug interactionsDrug overdosesEmergency medicineEnvironmental exposuresGraft vs. host

    Heat stroke

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    h em od y na mi c a nd c ar di ac m on it o ri ng ;neurologic monitoring including sedation,analgesia, delirium; laboratory values; etc.). Inaddition, these pharmacists should be familiarw it h p ha rm ac oe co no mi c a nd o ut co meassessments, ethical and legal considerations, riskmanagement and medication safety, ICU design,service delivery, and workforce issues. Allpharmacists need to be familiar with the health-systems processes for the delivery of medicationsand institution-specific policies or proceduresthat affect the care of ICU patients (e.g., clinicalpathways or protocols, medication reconciliation,medication safety, quality measures, pharmacyoperational processes, etc.). The ICU pharmacistmay represent a team of pharmacy personnel,each contributing unique expertise and skills. Inorder to maximize services, the pharmacist mustbe aware of the responsibilities and activities ofeach individual and may be required to integrateor lead the team.

    Direct pharmacy services

    While hospital-wide mortality rates decrease asthe pharmacist-to-occupied bed ratio increases,the primary factor contributing to this beneficialassociation is the involvement of pharmacists inthe direct care of patients with activities generallydeemed fundamental or desirable.1820 Guidelinesdeveloped by SCCM determined that pharmacistsare an essential component for providing qualitycare to critically ill patients and recommend theintegration of a dedicated pharmacist into theICU team.7, 8 The provision of pharmacy servicesin a manner that is proactive and directed at

    patient care decreases drug-related costs,

    prevents adverse drug events, improves thequality and efficiency of care, and is associatedwith reduced mortality, shortened length of stay,and lower overall costs.13, 15, 1826 Pharmacyservices associated with favorable healthcareoutcomes include18-21:

    Adverse drug reaction management Drug information Protocol management Admission medication history Disease state management

    Participation in patient care rounds Cardiopulmonary resuscitation

    Most of these services are fundamental activities.Unfortunately, recent survey results indicate thatpharmacists are providing direct patient careservices in only 62.2% ICUs, which is similar tothe 64.8% reported nearly twenty years prior.2, 27

    Skills for success

    Communication

    As the ICU pharmacotherapy specialist and

    l ea d er, t he p ha rm ac is t m us t e ff e ct i ve lycommunicate and interact with other disciplines.T he d ev el op me nt a nd re fi ne me nt o f communication skills is an essential componentfor advancement of pharmacy services into andwithin ICU practice. Communication in the ICUis key to a collaborative multidisciplinaryapproach, comprehensive patient care, andoptimizing outcomes through the provision ofeffective and safe pharmacotherapy.28, 29 Effectivecommunication is built on trust and crediblecl in ician s ar e th o se wh o b y th eir actio n s

    demonstrate and advocate the best interests of

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    Table 1. (continued)

    Therapeutic Area Specific Disease State, Condition, or Device

    Other Hypothermia (inadvertent and therapeutic)ImmunizationNutrition support (enteral and parenteral)Obstetrical crisesOrgan transplant and complicationsOrthopedic injuryPain managementPharmacoeconomicsPharmacokinetics, pharmacodynamics, pharmacogenomicsSolid organ neoplasmsSurgical proceduresThermal injuriesToxicologyTrauma (blunt and penetrating)

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    their patients. Pharmacists must be aware of therelationships established between the pharmacydepartment and the ICU and its practitioners.Therefore, frequent pharmacist-to-pharmacist orpharmacist-to-technician communication is alsoessential.

    Directly providing pharmacy services isassociated with beneficial outcomes.1820 Ideally,all pharmacists should assess patient needs at thebedside whenever possible and those providinghigher level services must be visible. A practicalapproach for the pharmacist to assess critically illpatients includes:

    O b ser ve th e patien t in additio n to th elaboratory, pharmacy, medical records, andinformation from other healthcare providers.

    Create a problem list, starting from the top ofthe patient and working down (e.g., head,neck, chest, abdomen, etc.) or by systems asoutlined in Appendix 1. Include all problems.Reco gn ize th at th e pr imar y ph ar macyproblem may not be the reason for admission.

    Evaluate the pre-ICU medical records. Lookcarefully at the events that occurred in theambulance, prior hospital, emergency oroperating room. Evaluate the past medicalhistory and determine the need to continuetherapy in the ICU. Request additionalinformation as needed (e.g., laboratory value).

    After developing a complete problem list,

    begin to integrate (impact of one problem onthe others) and prioritize problems.

    Collaborate with other members of thehealthcare team, including respiratorytherapists, nurses, dieticians, and physicians.L ear n h o w th eir activit ies impact th epharmacotherapeutic plan for the patient.Examples include:

    How do different ventilator settings impactthe required level of sedation?

    Wh at type of int ravascular access isavailable?

    H ow d o es n ut ri ti o n s up po rt i mp ac tpharmacotherapy?How does renal replacement therapy impactdrug metabolism / elimination?

    Formulate a comprehensive therapeuticmanagement plan for each problem thatincludes:

    Drug regimens and devices needed.Specific monitoring regimen (what andwhen).Communicate desired and unexpected (e.g.,adverse events, lack of effect) outcomes,

    including the monitoring regimen and

    reasons for discontinuation.Anticipate physiologic (e.g., acute kidneyinjury), pharmacologic (e.g., need for aninteracting agent), or process changes (e.g.,loss of intravenous access)

    Reassess daily the problem list and the

    therapeutic plan.Relying on information gathered and acted

    upon at an independent setting (e.g., pharmacyor office) may not encompass all the patient-specific clinical concerns. The presence andincreased visibility of being at the bedside createsthe opportunity to exchange patient-specificinformation and automatically engages thepharmacist in direct patient care that is oftenproactive rather than retroactive.1, 14, 15, 26, 30

    Efficiently extracting patient-specific informationb y a s k i n g k e y q u e s t i o n s t o g a i n a r a p i dunderstanding of the situation, listening to inputprovided by others, engaging in an exchange ofin for matio n, educatin g o th er s ab o ut al lpharmacotherapeutic options, and setting theexpectation for the selected drug regimens aresome of the many ways to communicate whileintegrating into the healthcare team and gainingconfidence that a pharmacotherapeutic plan willresult in expected outcomes.11, 31 A common flawof inexperienced ICU pharmacists is to consumetheir time in data collection, compiling orgathering vast amounts of available information

    at the expense of analyzing it, developing atreatment plan, and effectively communicating orimplementing the plan. To provide higher levelservices and truly be the pharmacotherapyexpert, the pharmacist must efficiently interpretd at a a nd l in k t he d at a t o t he ra pe ut icmanagement plans.

    P articipatin g in patien t care r ou n ds isbeneficial and expected according to SCCM.7, 8

    Efficient use of time and resources may limitattendance, but pharmacists should strive toattend rounds as frequently as possible. Ideally

    rounds occur at the bedside but they may occurelsewhere or via automated interactive systems.Some may choose to conduct independentpharmacy-driven rounds. The established ICUpharmacist may serve as much as a consultant asa clinician. Since many therapies used in theICU are technologically demanding, highlycomplex, and costly, a desirable goal for criticalcare pharmacy services is to share clinical,pharmacoeconomic, and outcomes research withthe ICU team.1, 7, 8, 11, 15, 20, 21 Involvement inpatient care rounds also provides educational

    opportunities for the pharmacist to learn from

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    other ICU professionals.Writt en co mmun ic at io n sk il ls ar e eq ua ll y

    important to the care of critically ill patients.Wh en in di ca te d, wr it te n co mmun ic at io n ordocumentation of pharmaceutical care activitiesshould include a concise explanation of the

    management plan. A focused pharmaceuticalcare plan should conclude with precise wordingo f a r eco mmen datio n th at may in clu de atherapeutic regimen and monitoring plan.

    Written communi cation, ho wever, shouldcomplement direct verbal interactions.

    Actively participating on ICU committees orhospital committees that affect the ICU providesthe pharmacist with several opportunitiesincluding establishing rapport with otherpersonnel, promoting rational and safe use ofmedicatio ns, educatin g o ther h ealth care

    professionals, and learning and applying thep o li ci e s t ha t a f fe c t p ra c ti c e i n t he I CU .Communication during committee meetings orinvolvement with committee actions (e.g., ICUp ro j ec t s, c li ni ca l p at hw a ys , p o li c ie s o rprocedures, quality improvement initiatives,medication safety, implementing new or revisedsystems, etc.) provide the pharmacist withadditional opportunities to exemplify theirunique knowledge of pharmacotherapy ofcritically ill patients. Similarly, informal (e.g.,inservices, pharmacy updates, project results,

    etc.) and formal education (e.g., lecture series,continuing education, etc.) of other healthcareprofessionals are opportunities to communicateprofessionally and demonstrate the pharmacistsrole as the pharmacotherapy expert. Similarly,the attendance of educational events conductedby other disciplines expands the pharmacistsscope of knowledge.

    Advanced problem solving / Critical thinking

    Optimizing patient outcomes in the ICU isdependent upon an organized and efficient

    approach to understanding and managingmedical problems or pharmacotherapy needs ofthe acutely ill. At the core of this skill is adetailed understanding of common ICU diseasestates (Table 1), patient-specific pathophysiology,drug action properties, evidence-based medicine,and patient-specific goals of therapy. Intertwinedwith didactic and experiential work is the abilityto in tegr ate mu ltiple so u rces o f medicalinformation. Data assimilated from the patient orfamily interview, other healthcare professionals,medical profile, physical assessment, laboratory

    examination, and other diagnostic tests providethe pathophysiologic pieces of the puzzle neededt o c re at e a n a cu te p ro bl em l is t w it hcorresponding differential diagnoses. Once aproblem list or specific issue is established, acomprehensive and realistic care plan can be

    d ev is ed a nd i mp le me nt ed . C on ti nu alreassessment and revisions of the treatment plansh o u ld b e an ticipated as n ew o r adju stedinformation is common in the ICU. To ensurethe pharmaceutical care provided to the patient iseffective, safe, an d appr o pr iate given th epotentially rapid changes in their clinicalpresentation, skill in intensive monitoring mustbe developed. Key to the mastery of problemsolving in the ICU is the ability to establishmanagement plans early with therapeutic goalsand anticipated outcomes (see list above). The

    plan, goals, and outcomes need to be seriallyassessed and frequently revised. Therefore,efficiency and sound clinical judgment arefundamental to critical thinking. The pharmacistshould preemptively prepare a management planfor unexpected outcomes, adverse events, or newdevelopments (e.g., acute renal dysfunction).Unexpected outcomes or adverse events shouldbe rationalized by the pharmacist in an attemptto avoid reoccurrence.

    Another component of critical thinking iselucidating issues that indirectly affect patient

    care. These may include workflow parameters,p ha rm ac y o r I CU s t ru ct ur e, p o li ci e s o rp ro c ed ur es , t he a c ti o ns o f c o mm it t ee s ,technology, etc. Judgment and communicationare keys to effectively dealing with issues thatindirectly impact patient care. While the ICUpharmacist offers unique knowledge and skillsthat may guide interpretation or application ofthese issues, all interested parties should beconsulted since the issue may affect others.Similar to the patient care approach, the ICUpharmacist should anticipate potential indirect

    patient care concerns and preemptively manageor communicate the issue.

    Other skills

    Judgment, leadership, organization, and timemanagement are essential skills that are difficultto learn but should be developed over timethrough continual application and practice.Experienced practitioners may help the ICUph ar macist develo p th ese skil ls. Becau seincreased stress is associated with the care ofcritically ill patients, the pharmacist should be

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    prepared to accommodate th e emotio nalresponses that are common. These responses areoften natural, and planned activities to helpalleviate stress are sometimes needed (e.g.,communication, exercise, relaxation, etc.).

    Project Management / Scholarship

    Project management and scholarship areconsidered desirable or optimal to critical carepharmacy practice.1 Scholarship refers to theassimilation and dissemination of information inany format at any level. At the foundation of thisskill is the creation and capture of outcomemeasurements and reporting systems thatfunction in the context of each individual ICUsetting. The goal of collecting, analyzing,reporting, and ultimately implementing systems

    based on project findings is to lessen variabilityin the delivery of care, thereby optimizingoutcomes, reducing errors and enhancing safety,and improving resource utilization. Therefore, toadvance the profession of critical care pharmacy,pharmacists practicing at the fundamental levelof service should participate in the development,implementation, and data collection of protocolsand medication utilization evaluations. At thedesirable level of service, pharmacists are projectmanagers and lead the assessment of guidelines,protocols, practice changes, or performance

    improvement initiatives in the ICU. Optimally,the ICU pharmacist is the project champion ofhypothesis driven initiatives. Internal andexternal dissemination of case reports, projectresults, or pertinent review articles should beexpected of all pharmacists practicing at alllevels. In addition, all pharmacists shouldparticipate in developing ICU or institutionalpolicies, procedures, clinical pathways, and theeducation of others. Pharmacists should attemptto present their findings at local and regionalmeetings of critical care professionals and strive

    to disseminate their results at national andinternational conferences. These initiativesshould be supported by the institution and itsconstituents and affiliates.

    Training and Preparing the ICU Pharmacist

    Education

    Conventional

    The training and preparation of pharmacistsproviding care to critically ill patients is currently

    not standardized and may take several successful

    pathways. In the United States, all professionalph ar macy pr o gr ams lead to th e do cto r o f pharmacy degree.4 The ACPE outlines standardsand guidelines that emphasize communicationskills, cu rr iculu m co n ten t, educatio n ala s se s sm en t a nd o ut c om es , e x pe r ie nt ia l

    education, interprofessional teamwork, patientsafety, professional competency, professionalism,and scholarship amongst other key educationalcomponents.4 Several white papers prepared bythe ACCP further delineate the educationalrequirements for the didactic curriculum,17

    experiential education,32 professionalism,33, 34

    interprofessional networking,35 and exposure toresearch.36 Therefore, the doctor of pharmacydegree provides the core skill sets and knowledgefor graduates to function as competent clinicians.Curricula, however, should be flexible enough to

    accommodate students desiring additionaltr ain ing, eith er didactical ly o r th ro u ghexperiential exposure, in particular domainsincluding but not limited to research, teaching,administration or management, and specialtypractices like critical care.

    Individuals desiring to practice in an ICUenvironment enter residency training shortlyafter receiving their pharmacy degree.15 The firstyear resident, or postgraduate year one (PGY1),should be exposed to a variety of experiencesthat include multiple clinical subspecialties,

    project management and scholarly activities,teaching opportunities, and administrativefunctions.37 The individual may then choose topursue a second year of specialty training, orpostgraduate year two (PGY2). Critical care isrecognized by ASHP as a specific area for PGY2pharmacy residency training. ASHP is theo rganizatio n th at accredits al l ph ar macyresidency programs (PGY1 and PGY2).37 As ofMay 2011, 85 critical care residency programs areeither available or in the ASHP accreditationprocess. Information on the outcomes, goals,

    objectives and standards of residency programsmay be found online at the ASHP website.37, 38

    Individuals completing PGY1 residency programsshould have the knowledge base and skill sets toprovide desirable pharmacy services to ICUpatients with the expectation that optimalservices be easily incorporated into practice. ThePGY2 residency is directed by an experiencedcritical care pharmacist and is designed todevelop an independent practitioner withadvanced knowledge and skill sets. Therefore,these pharmacists should be capable of providing

    optimal services. Only 11.1% and 5.9% of

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    pharmacists providing critical care pharmacyser vices h ave co mpleted P GY1 an d P GY2residency training, respectively.2 Pharmacyorganizations have independently and jointlyproposed that residency training for newpharmacists become mandatory before entering a

    patient-care practice by the year 2020.9, 39, 40While this would standardize the training, ensurec o ns is t en t p re pa r at io n o f c ri ti c al c a repharmacists, and lead to higher levels of servicesbeing provided, pharmacy graduates substantiallyo u tnu mber availab le r esidency pr ogr ampositions. 3 7 , 3 8 , 4 1 A key ch allen ge fo r th epharmacy profession as a whole is to providesufficient training programs to meet futuredemands and the growing needs of all thesubspecialties.4244 This section of the article willfocus on developing and preparing the working

    pharmacist wanting to transition to or achievehigher level pharmacy services in the ICU.

    Unconventional

    A common cause linked to medication errorsand adverse drug events in ICUs is the limitedknowledge related to pharmacotherapy by theprescriber.4554 Therefore, any pharmacistwanting to practice in the ICU must havecomprehensive knowledge of key ICU topics thatare representative of their population of criticallyi ll p at i en ts ( Ta b le 1 ) . S im il ar ly, t he s e

    pharmacists must possess or be willing tod ev el op t he s ki ll s re qu ire d t o p ro vi depharmacotherapy management. These may belearned through didactic lectures, active problemsolving activities, or experiential opportunitiessuch as on-the-job training, mini-sabbaticals,mentorship programs, masters or nontraditionaldoctor of pharmacy programs. Recognizing keysources of information and identifying a mentorare key to acquiring the necessary knowledge,resources, and skills.

    Literature

    Recognizing sources of information that canassist pharmacists in keeping current on thelatest developments in patient care or gainadditional expertise out of their daily scope ofpractice is key to professional development.Examples include peer reviewed journal articles,tertiary texts, or electronic and on-line resourcesthat are easily accessible. Table 2 providesexamples of journals that frequently publisharticles related to critical carepharmacotherapy.5558 Unique sources of compre-

    hensive information are articles that compile andbriefly summarize primary literature that areclinically relevant to a specific area of practice,including ICU pharmacotherapy.5558 Consensusguidelines and systematic reviews may providegeneral information but the pharmacist providinghigher level services must critically evaluate andclinically in ter pr et th e pr imar y stu dies.Preselected critical care abstracts from various

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    Table 2. Examples of Journals Frequently PublishingCritical Care Related Articles.5558

    Type of Critical CarePharmacotherapy Articles Journal

    Common Publications American Journal of CriticalCare

    American Journal of Respiratory and Critical CareMedicine

    Anesthesia and AnalgesiaAnesthesiologyChestCritical CareCritical Care ClinicsCritical Care MedicineHeart and LungIntensive Care Medicine

    Journal of Critical CareJou rn al of Tra um a In ju ry,

    Infection and Critical CareSurgery

    Landmark Publications Annals of Internal MedicineArchives of Internal MedicineBritish Medical JournalN ew E ng la n d J o ur na l o f

    MedicineJou rn al of th e Am er ic an

    Medical AssociationLancet

    Subspecialty Publications American Journal of Health-System Pharmacists

    Annals of Emergency MedicineAnnals of PharmacotherapyAnnals of SurgeryBurns

    Clinical Infectious DiseasesEmergency Medicine JournalGastroenterologyHepatology

    Journal of Emergency MedicineJou rn al of Pa re nt er al an d

    Enteral NutritionNeurocritical careNeurosurgeryPediatricsP ed ia tr ic C ri ti ca l C are

    MedicinePharmacotherapyTransfusionTransplantation

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    journals may be purchased so the pharmacistdoes not need to regularly search each journal.Publishers may send free alerts of new issueswith article titles and abstracts. Online searchengines may offer filtered searches. A number ofresources are available in an electronic version

    including texts, journals, and personal digitalassistants (PDA) that allow access anywhere,including the bedside.59 Over 135 additionalweb-based resources in a variety of e-learningformats are available for critical care education.60

    The pharmacist desiring to provide higher levelservices must apply the available literature in amanner that takes into account the ICU-specificpatient population, practice patterns, andhospital processes and structure. In addition,several organizations such as the ACCP PRNs,SCCM CPP section, and ASHP critical care and

    emergency medicine network provide ICU-specific education and networking opportunitiesfor practice, education, and scholarship. Journalc lu b s m ay b e a v ai l ab l e t hr ou gh v a ri ou sinstitutional departments or the aforementionedorganizational networks.

    Mentors

    Mentors play vital roles in developing anda dv a nc in g t he l ev e l o f c ar e p ro v id ed b ypharmacists.61 Mentoring may occur in multiple

    ways including co-workers, experts in the field,other critical care practitioners, or nonICUpersonnel and may be formal or informal.Identifying and developing good mentors isimportant for facilitating the learning process.Mentors may be chosen or assigned, but ingeneral, the strongest mentorship relationshipsd ev el op o ve r t i me . A n i n di vi du al I CUpharmacist may have several mentors at any onetime or an individual mentor may lead a processthat designates preceptors to develop specificeducational components or skill sets.

    Ideally, an inexperienced pharmacist shouldseek a mentor with insight into critical carepractice so they may provide skill developmentor enhance the understanding of approaches toassessing and managing critically ill patients andtheir disease sates.61 NonICU personnel (otherclinicians or academicians) may serve as mentorsas they may provide skill development or careerguida nc e app licab le to the ICU. Aninexperienced pharmacist should pursue amentor who is geographically close enough thatregular meetings are easily arranged. When a

    nearby mentor is not available, communicating

    b y e -m ai l o r t el e ph on e m ay b e f e as i bl ealternatives to face-to-face meetings.62 A moreexperienced pharmacist may not require directmentorship or may seek mentors with expertisein a specific skill set (e.g., project management /scholarship, administration, teaching, specialized

    setting, etc.). The trainee may observe variousapproaches used by practitioners to considerwhich settings to emulate as they develop theirown approach to being the pharmacotherapyspecialist providing direct care of critically illpatients. The time required to develop thetrainee into an independent pharmacist providinghigher level services will vary according to thepractice site(s), the baseline knowledge and skills e ts o f t he t ra in ee , a nd t he p re c ep t in gresponsibilities of the mentor.

    In order for pharmacists to move toward

    providing higher level services, educationalexperiences must provide opportunities to learnand apply the core therapeutic topics (Table 1).A good mentoring relationship will assist tofurther gain knowledge and skills by directlyi nv ol vi ng t he t ra ine e i n c ri ti ca l c arepharmacotherapy.61, 63 A mentor / preceptorshould guide pharmacists in dealing with usualdaily ICU challenges including patient careissues, skill development, problem solving and

    judgment, critical thinking, multidisciplinaryteam interactions and communication, and time

    management and task prioritization. The processof learning through experience and caring foractual patients needs to be active and continuouswith subtle but consistent supervision. Whiletrainees should feel independence to learn andpractice as the pharmacist on themultidisciplinary team, it is equally important toprovide a safety net such that the trainee canl ea r n w it ho ut w or r yi ng a b ou t p o te nt ia ldetrimental outcomes. One major component oflearning is continuous improvement. Mentorsand preceptors need to provide trainees with

    opportunities to learn, make mistakes withappropriate oversight, and reflect on how toimprove their skills while encouraging them andmaintaining an excellent level of pharmaceuticalcare. A safe environment with a practice leaderwho provides guidance will assist the new ICUph ar macist to develo p th e skil l sets an dconfidence necessary to function independently.Th e mento r sh o uld pr ovide feedb ack o nsuccessful approaches and help mold the traineesability to represent themselves when discussingpatients and providing recommendations for

    improving patient care. Collaboration in the ICU

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    is essential for maximizing outcomes. Therefore,it is imperative that trainees integrate themselvesand be responsible to the multidisciplinary teamfor patient care and for the team to view thetrainee as the pharmacotherapy specialist. Aneffective ICU team will engage in all types of

    interactions, including some that may involveincorrect information, disagreements, and othercontroversial topics (e.g., social issues, religiousor cultural beliefs, etc.). Trainees need to berespectful of other members of the team and actprofessionally with ethical diligence andempathy.

    The mentoring relationship may extend toissues such as guidance for policy and protocold ev e lo p me nt , a dm in is t ra ti v e t r ai ni ng ,accreditation exposure, and assistance withscholarship.63-67 Whenever possible, the mentor

    should involve the trainee in committees,hospital projects, and teaching opportunities thatinvolve various audiences and formats. Thepreceptor must ensure the appropriate level ofinformation is conveyed in a manner conduciveto learning for the targeted audience. Writtencommunication skills should be developedthrough practical application. In some cases, them en to r m ay a ss is t w it h p ro fe ss io na lrelationships, guide career development, andprovide counseling for personal challenges.Eventually the pharmacist requiring mentorship

    should strive to develop into the role of thementor.

    Resources Available

    A n e st ab li sh ed n et wo rk o f n on -I CUpharmacists who offer practical knowledge is avaluable resource to the critical care pharmacist.These individuals may serve as advisors, provideexamples of pharmacy practice models, or offerunique knowledge of emerging or changingtherapies that potentially affect critically illpatients (e.g., oncology, neurology, nutrition

    support, transplant, infectious diseases, etc.).Another resource available to all pharmacists isth e educatio n al o ffer ings o f cr it ical careconferences (e.g., SCCM Annual Congress).These multidisciplinary meetings providepractice perspectives of challenging patient careissues, clinical application of emerging data, andthe opportunity to create networks of critical carecolleagues. Pharmacy specific conferences (e.g.,A SH P M id ye a r C li ni c al M ee ti ng , A CC Pmeetings) provide excellent opportunities toliaise with pharmacists practicing in critical care

    or other specialties, who may offer examples ofinnovative pharmacy practice models or skillsand knowledge that may be applied to the care ofcritically ill patients. Involvement in critical carea nd /o r p ha rm ac y o rg an iz at io ns o ff er sopportunities to develop skills of effective

    communication, leadership, organization, andtime management. The pharmacist must becommitted to continual learning and professionaldevelopment to maintain scope of knowledgeand applicable skills.

    The ASHP Research and Education FoundationCritical Care Traineeship offers participantspractical experiences in designing patient-specificpharmacotherapy, solving drug therapy problems,and developing protocols / guidelines andpolicies related to the care of critically illpatients.68 The SCCM CPP section provides a

    mentoring service for ICU pharmacists desiringassistance in various activities (practice,education, administration, or scholarship). Mini-sabbaticals may be available through variousorganizations and allow developing pharmaciststo travel to sites where an established pharmacistcan provide advanced training opportunities.Ideally these programs will be expanded andstructured to provide coordinated opportunitiesfor individuals to expand their skills and applytheir knowledge. Few pharmacy schools andsome organizations (e.g., ASHP, ACCP) have

    developed programs designed to advanceparticular skill sets (e.g., teaching, projectmanagement / scholarship, leadership, etc.).

    Support for a training environment

    Administrative support for the developingpharmacist on the critical care team should beproactive. Support should come from thedepartment of pharmacy, ICU directors andmanagers, and hospital administrators but maybe required from other interested parties, such asaffiliated academic departments, government

    agencies, payers, patient advocacy groups, orother healthcare providers. In order to optimizepatient care, pharmacists, their employers, andICUs must advocate for their presence anddemonstrate their importance in the ICU.

    Support may involve creating and funding theposition, advancing the professional growth ofthe individual pharmacist, allowing sufficienttime to achieve successful outcomes, identifyingmentors and preceptors, or process changes thatco n tin ually pr ogr ess ph ar macy ser vices.Networks of affiliated institutions, academic

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    centers, or organizations with establishedresidency programs may create an in-housetraining program that is designed to address theneeds of the trainee. Financial support and timea ll ot me nt t o f os te r a nd e nc ou ra ge t heprofessional development of the pharmacist is

    essential. This may include formal mechanismsof training, mentoring, or mini-sabbaticals.Reso u r ces sh o u ld b e al lo cated th at al lo wpharmacists to obtain the necessary training andcredentials required to practice in the ICU, joinprofessional organizations, and attend theconferences supported by those organizations.Pharmacists provided with these opportunitiescan network, advance their knowledge, andrefine approaches to managing their patients.This allows the institution to keep current onapproaches to patient care as the information is

    disseminated internally to other healthcareproviders. The dissemination of institution-specific scholarship at professional conferencesmay provide recognition to the institution.Enhanced patient care associated with theprovision of training and advanced pharmacyservices must be of value to the institution,especially during times of fiscal constraint.69 Ins o me c as e s, h av in g q ua l if i ed p ha rm ac ypreceptors to create additional formal trainingopportunities for students, residents, and othertrainees may generate revenue that may partly

    offset the training and support of the critical carepharmacist.69 The opportunity for additionaltraining enhances career satisfaction and may aidi nd iv i du al d ev e lo pm en t a nd e mp lo y eeretention.70 In order to maximize their return oni nv es t me nt , h os p it al s a nd /o r a c ad em icinstitutions should consider the benefits ofcollaborating with experiences gained internallyor from other institutions.

    Credentialing Pharmacist for Critical Care

    Pharmacist credentialing is a contentious issue.

    Credentials are desirable for professionals, butattempting to define or clarifying the requiredcredentials for pharmacists providing variouslevels of service remain controversial. The focusof this section of the document is to project thecredential requirements for pharmacists caringfor critically ill patients. This serves as anopportunity to define the expectations of ICUpharmacists for all interested parties and isintegral to the advancement of pharmacy practicein the ICU setting, since they may be used forin stitutio nal pr ivi legin g, el igib i li ty fo r

    reimbursement from governmental and privatepayers, accreditation of residency trainingprograms, and numerous other internal andexternal evaluations. For the purpose of thefollowing discussion, credentials, accreditation,certification, and related processes are those

    defined by the Council on Credentialing inPharmacy (CCP).9

    Credentialing history

    Credentialing, defining credentials, anddesigning processes to verify and maintaincredentials is not limited to the profession ofpharmacy. The Accreditation Council forGraduate Medical Education (ACGME) isresponsible for establishing general requirementsfor medical residencies and developing the

    process of accrediting programs.

    71

    The AmericanB o ar d o f M ed ic al S pe ci a lt ie s ( AB MS ) i sresponsible for certifying specialists.72 Th epharmacy profession parallels medicine in thatASHP is responsible for establishing requirementsand accrediting pharmacy residency programswhile the Board of Pharmaceutical Specialties(BPS) is responsible for credentialing pharmacyspecialists.73, 74 Like medicine, recognition ofpharmacy specialty areas requires the presence ofa distinct body of scientific knowledge, appro-priate number of candidates who concentratetheir practice in the area, professional support,presence of training programs with appropriatedepth and scope, and candidate requirements.75

    Characteristics of successful certificationpr o gr ams h ave b een defin ed an d in clu dewidespread professional acceptance, marketpenetration beyond the profession (e.g., demanddriven by payers or employers), identification asthe major source of professional specialtyrecognition, associated beneficial outcomes andc os t- ef fe ct iv en es s, a nd e co no mi ca ll ysustainable.75

    Over the past two decades, there has been an

    explosion of interest in the credentialing ofhealthcare providers.7578 In 1989, JCAHO (nowtermed TJC) required acute care institutionsseeking accreditation to confirm the credentialsof the medical staff and upon review of theinformation determine privileging status withinthe organization. The metrics for evaluatinghealthcare provision has changed to include agreater emphasis from payers on the quality ofcare provided. In addition, the general public ismuch more informed of health care quality andstan dar ds o f pr actice, du e in par t to th e

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    widespread dissemination of information onquality and medical errors found in variousreports including the Institute of Medicine. Thisincreased attention to healthcare quality hasspawned the creation of a number of public andpolitical advocacy and research organizations

    focused on optimizing quality of care. Whilemany organizations utilize credentials assurrogate markers of practitioner knowledge,skills, and attitudes; there are very little datacorrelating the attainment or maintenance ofparticular credentials with improved quality ofcare o r co st- effective fo r an y h ealth carediscipline. This is particularly absent in theprofession of pharmacy.75

    Current pharmacy credentials

    The CCP was formed in 1999 and is a coalitionof 13 pharmacy organizations committed top ro v id in g l ea d er s hi p , g ui d an ce , p ub li cinformation, and coordination for credentialingprograms in or relevant to pharmacy.9 Table 3outlines current pharmacy credentials.74, 75 As of

    June 2004, the education credential awarded tothose students completing collegiate studies isthe doctor of pharmacy degree.4 Pharmacylicensure is regulated by each states board ofpharmacy. Upon the receipt of the doctor ofpharmacy degree and the completion of a

    specified n u mb er o f pr actice h o u rs, th ei nd iv i du al m ay c o mp le t e t h e l i ce ns i ngexamination. Additional requirements topractice may be determined by the state in whichpractice will occur. Pharmacists who wish toadvance their knowledge or skills may alsoa cq u ir e a d di ti o na l c re d en ti al s t hr ou ghpostgraduate education, training, or credentialing(Table 3). Of note, the methods used by theseorganizations to approve these credentials varyfrom knowledge-based tests to experientialpractice hours.

    In pharmacy, credentialing requirements byinstitutions have focused on meeting TJCstandards. Most acute care institutions meetthese standards by performing a pre-employmentreview of the pharmacists credentials. Thispredominately involves confirmation of theappr o pr iate degree an d l icen sur e. So meinstitutions have expanded upon this by eitherincorporating specific credentials required oroutlining a privileging process to match specific

    job descriptions. In the future, it is anticipatedthat additional credentialing will be necessary to

    provide higher levels of pharmacy services.

    These services and associated credentials will beexpected by interested parties in order to meetexpanding accreditation benchmarks, meet theneeds of the evolving pharmacy educationalsystem, an d meet in sti tu tio n al an d payerstandards for provider status and reimbursement.Some of these changes have already started as then ew es t v er si on o f t he A SH P re si de nc yaccreditation standards for PGY2 residenciesrequires program directors to obtain BPScertification when certification is offered in thatspecific advanced practice area.37

    Pharmacy statements

    The mission statements of both ACCP andASHP focus on support and advancement ofpharmacists and pharmacy practice.77, 78 Theirvisions suggest the practice of pharmacy shift itsfocus from managing products to patient care. Arequired element for the occurrence of this shifti s t o d ev e lo p c re d ib le a nd c o or di na t edcertification and credentialing processes forpharmacy practitioners. Licensure alone will be

    insufficient if pharmacists are to be the experts in

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    Table 3. Current Pharmacy Credentials/Certifications.74, 75

    Credential / Certification Program(s)

    Education Doctor of Pharmacy (Pharm.D.)

    Postgraduate Education MastersDoctor of Philosophy

    Postgraduate Training Postgraduate Year 1 Residency

    Postgraduate Year 2 (Specialty)Residency

    Fellowship

    Credentials/Certifications Ame ric an Acad emy of Pai nManagement Credentialed PainPractitioner

    American Council for PharmacyEducation certificate programsa

    Commission for Certification inGeriatric Pharmacy

    Diplomat of the American Boardof Applied Toxicology

    National Institute for Standardsin Pharmacist Credentialingb

    B oa rd o f P ha rm ac eu ti ca lSpecialties

    C re d en t ia l s i n n u cl e ar,nutrition support, oncology,p h a r m a c o - t h e r a p y ,psychiatry, and ambulatorycare

    A d de d qu a li f ic a ti ons i ncardiology and infectiousdiseases

    ano longer offeredbprogram expired December 31, 2008.

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    optimizing the use of medications and thes ys te ms i n wh ic h t he y a re d el iv ere d.R e co mm en da ti o ns r el a te d t o p ha rm ac ycredentialing and to the knowledge, skills, andabilities they are meant to represent are evidentthroughout numerous pharmacy organizational

    documents. The Task Force on ChangingD emo gr ap hi cs e nc our ag es p ha rm ac ypractitioners to pursue a lifelong process ofmaintaining competency with respect to issuesthat have a bearing on patient outcomes andpractitioner team effectiveness.79 Otherrecommendations include a vision for entry-levelpharmacists to complete PGY1 training and forthose practicing in highly specialized areas tocomplete PGY2 training.39, 40 Additionally, mostclinical pharmacists will need to obtain anappropriate specialty certification, such as those

    currently offered through BPS.7 4 , 8 0 ASHPre co mm en ds t ha t b y t he y ea r 2 02 0 a llpharmacists providing direct patient care mustco mplete r esidency tr ain ing.81 Theserecommendations of advancing credentialing andt ra i ni ng r eq ui re me nt s a re b a se d o n t herecognition that pharmacists will be involved inall patient care settings, that pharmacists willassume responsibility and accountability formanaging drug therapy, and that pharmacists willb e r ec o gn iz ed b y p a ye rs a s h ea lt h c ar eproviders.74 It is anticipated that credentialing

    will be based on the application of knowledgeand the demonstration of performance.

    Critical care statements

    In the position paper endorsed by ACCP andSCCM, levels of service, service providers, andscope of service were outlined.1 Stratifying adultICU services by level resulted from data andoutcomes identified from the American Collegeof Surgeons (ACS) applied to trauma centers.L ev el 1 c ri ti ca l c are c en te rs p ro vi decomprehensive care and treat a wide range of

    patient populations.7 In addition to orderfulfillment, this document states that it ise s se nt i al t ha t t he p ha rm ac i st h av e t hequalification and competency necessary toprovide pharmaceutical care in the ICU.7

    Qualifications have been described as advanceddegree, po st- graduate tr ain in g, o r o th erspecialized practice experiences. Level 2 centersprovide comprehensive care for select areas ofexpertise. The expectation for personnel andservices are the same as in Level 1 for thesepatient populations. Level 3 designation differs

    primarily because institutions provide limitedcritical care services and focus on patientstabilization and coordination of patient transferto an appropriate comprehensive care center.Pharmacy services for these centers focus onmedication system processes. Recognizing that

    critical care encompasses several distinct patientpopulations, SCCM has since emphasizedpractitioner certification for optimal delivery ofcare for all critically ill patients.7, 8 Unfortunately,the specific certification requirements forpharmacists were not delineated. The scope ofcertification, however, is expected to varydepending upon the level of service and thespecific patient population.

    Recommended credentials for critical carepharmacist

    Recommendations for credentials of criticalcare pharmacists are based on currently availablecredentialing mechanisms.74, 75 It should benoted that considerable disparate opinionsex isted amo ngst th o se fo r mu lating th eserecommendations. This likely reflects thegeneral critical care pharmacy community.75

    Therefore, idealistic methods of optimizing thesecredentials are also presented in hopes that theprofession will consider similar methods ofverifying competencies in the future. Table 4outlines the recommended credentials andprovides a template for idealistic credentials.74, 75,82, 83 Purposefully absent in this document arepotential implementation strategies, time linesfor achieving change, and the identification ofthe agencies responsible for administrativeo ver sigh t as th ese wil l b e deter min ed b yin dependen t go ver n in g, r egu lato ry, an daccreditation entities. Several professionalorganizations, however, have vision statementswith targeted dates for their recommendations tobe implemented.77, 78 It is recognized thatachieving these credentials will vary based uponinstitutional structure, practice models, thepharmacy department, and the pharmacist.Therefore, it is highly unlikely that a single pathwill achieve the requirements for all involved inthe credentialing process.

    I t i s r e c o m m e n d e d t h a t t h e p r o c e s s o f credentialing involve a graduated system thatprogressively develops the requirements acrossthe level of pharmacy services.82 Pharmacistsproviding fundamental services should posses thebasic licensing credentials; whereas thoseproviding desirable and optimal levels of service

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    should complete additional PGY1 and PGY2,respectively. Recommendations for experience

    equivalent to residency training have beenproposed; however, currently there is notconsensus on this issue. One approach describedby a recent ACCP statement recommends thatPGY1 training equivalency should be portfolio-based and incorporate a personal statement,academic credentials, valid license, feedback fromcolleagues, and documentation of at least fiveyears of experience with activities involvingdirect patient care services, practice management,medication use management and medicali nf o rm at i cs , p ro j ec t m an ag e me n t, a n d

    educational services.83

    Pharmacists practicing incr it ical car e fo r th r ee year s o r wh o h avecompleted a PGY1 residency are eligible to sit forthe BPS Pharmacotherapy specialty examination.These requirements are advantageously perceivedby new practitioners.84 Ideally, a critical carecredential should be available that would beobtained after successful completion of the PGY2specialty residency or equivalent experience. Atthe time of writing, CCP is discussing theo ptimal credential ing fr amewor k fo r th eph ar macy pr o fession . I n additio n, BP S is

    exploring several new specialties areas, including

    critical care. The reader is encouraged tomonitor for these developments.

    Several limitations of these credentials exist.In both the medical and pharmacy literature, thelack of efficiency in the documentation andverification of credentialing is a frequently citedissue. Ideally, there would be a single repositoryfo r th e cr eatio n an d main ten an ce o f th isinformation, allowing individuals to makeseamless workplace transitions in their careers.Such a system would also be beneficial foremployers since all verified documents wouldexist in one databank and there would bepotential to make the information available to the

    p ub l ic . A no t he r i s su e i n t h e p h ar ma cyprofession is the lack of validation of thecurrently available credentials against thecharacteristics associated with successfulprograms.75 Also, currently available credential-ing avenues may not assess the competencies ofthose with established pharmacy practices orth o se pr acticin g in su b specialt ies (e.g. ,neuroscience, burn, etc.). Furthermore, todayscredentials may not reflect the necessity of othertypes o f cr eden tials in th e fu tu r e as i t isanticipated that the pharmacists clinical

    responsibilities and accountability will increase.

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    Table 4. Credentialing Recommendations for Pharmacists Providing Critical Care Services.74, 75, 82, 83

    Level ofPharmacy Service Recommended Credentials Ideal Credentials

    Fundamental Pharmacy Degree Same as recommended credentials under desirableActive state licensure level of pharmacy service

    1-2 weeks of mentored clinical exposure every 5-7

    years and/or focused continuing educationDesirable Pharmacy Degree Same as recommended credentials under desirable

    Active state licensure level of pharmacy servicePostgraduate training year 1 or similar traineeship Portfolio review every 5-7 yearsor equivalent experience

    Board of Pharmaceutical Specialist certificationin PharmacotherapyAdvanced Cardiac Life Support certification

    Optimal Pharmacy Degree Same as recommended credentials under optimalActive state licensure level of pharmacy service

    Portfolio review every 5-7 yearsPostgraduate training year 1 or similar Possible onsite competency assessmenttraineeship or equivalent experiencePostgraduate training year 2 in critical careor related practice (e.g. emergency medicine,

    transplant, etc) or equivalent experienceBoard of Pharmaceutical Specialties certificationin appropriate areaAdvanced Cardiac Life Support certification

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    Consideration may need to be given to assessingpractical skills and/or structuring credentialingexams differently that allow pharmacists todemonstrate higher order cognitive skills orspecific skills applicable to a specialized practice.Finally, increasing utilization of competency

    assessments will likely become a focus of futurepharmacists seeking to obtain and maintain highlevel practice credentials.

    Ideal credentials

    Credentials should advance the level ofpractice and signify designated competencies thatreflect skills required for performance. Thec o mp et en ci e s m us t a dv a nc e k no w le dg eassessment to include other core skill sets. Thefollowing discussion focuses on ideal credentials

    that critical care pharmacists should posses toprovide the various levels of services. Thecritical care pharmacy community endorses thef o ll o wi ng m od e l a s a n e x am pl e t ha t t heprofession in general should pursue whenestablishing required credentials in the future(Table 4).74, 75, 82, 83 The proposed model is acombination of currently available credentialsand the frameworks used in the United Kingdomwhere pharmacists may be assessed at levels ofgeneral pharmacy, advanced, or consultantafter submitting a portfolio that is evaluated

    based on demonstrated competencies by acollaboration of pharmacy reviewers termed theCompetency Development and Evaluation Group(CoDEG).85, 86

    The basic credentials for all levels of servicesa re i de nt i ca l t o t ho s e f o r r ec o mm en de dcredentials except that PGY1 training (or similarexperiences) and BPS certification may becomem an da to ry f or p ha rm ac is ts p ro vi di ngfundamental services (Table 4).74, 75, 82, 83 This isin accordance with the recommendations ofvarious professional organizations and should

    ensure the basic knowledge level and skillsrequired to provide pharmacy services toc ri t ic al l y i l l p a ti en ts a nd o t he r p a ti en tpo pulatio n s. I t is an ticipated th at man ypharmacists currently providing fundamentalservices would possess experiences similar toPGY1 training.83 In order to maintain practicalskills and competency, all pharmacists providingfundamental services may periodically spend ashort period of time in a mentored direct patientc are I CU e nv iro nm en t. B ec au se t he sepharmacists may provide fundamental pharmacy

    services to various hospital units, it is anticipated

    that they may have several mentored exposuresof direct patient care across various patientpopulations. Alternatively or in addition,c o nt in ui ng e d uc a ti o n p ro g ra ms m ay b edeveloped to maintain competencies for thesepharmacists.

    Wh at al so di ff er s fro m th e re co mm en de dcredentials is a mechanism for peer review thati nc lu de s c om pe te nc y a ss es sm en ts f orpharmacists providing desirable and optimallevels of service. These pharmacists may submita portfolio that is externally and independentlyassessed by pharmacy practice experts (bothcritical care and non critical care) through thedevelopment of a specialist board, comprisingclinical experts, academicians, and managers.Solicited appraisal from other entities (e.g., peers,professional colleagues, other ICU healthcare

    employees, trainees, subordinates, state licensingbody, etc.) is recommended. This peer reviewmodel is similar to the processes used forp ro mo ti on o f f ac ul ty i n a ca de mi a, t hedesignation of fellow by critical care andpharmacy organizations, and the peer reviewprocess implemented by the Veterans HealthAdministration in 2008.87 It is also similar inp hi lo so ph y t o t he p ro ce ss o f ad de dqualifications currently offered through BPS inthe areas of infectious diseases and cardiologybut differs substantially in structure and rigor. A

    similar model using competency assessment andoutcome documentation has been introduced inAlberta to facilitate pharmacist prescribingauthority in their scope of practice.88

    P o rtfo lio r equ iremen ts, co mpetenciesevaluated, and rating levels may differ accordingt o t h e l ev el o f s e rv ic e. F or e xa mp le ,competencies assessed under desirable levels ofservice may include safe and efficient drugdistribution, patient care delivery, personal traits(e.g., communication, leadership), problemsolving, management/organization, education,

    a nd p ro j ec t m an ag e me nt . T h e p o rt f ol iorequirements for optimal services may beexpanded to also include expert professionalpractice, advanced problem solving, systems andorganizational management, education/trainingdevelopment, research/evaluation, and publichealth initiatives. Different rating scales mayexist for different levels of service; pharmacistsproviding desirable services may need to becompetent at ratings of foundational to excellentbut ratings of excellent to mastery may berequired to provide higher level services. Similar

    to the systems used to accredit residencies by

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    ASHP,37 pharmacy schools by ACPE,4 andinstitutions by TJC,3 onsite observations of skillscould be integrated into the model as a methodof assessment, especially for determiningcompetencies of optimal service.

    As mentioned, the proposed competency

    assessment model is conceptually similar to theframework currently being implemented in theUnited Kingdom.85, 86 The framework in theUnited Kingdom was endorsed by regionalhospital agencies and flowed to the pharmacyprofession. A key to implementing a similarsystem in the US will be institutional andgovernment support since it is the professionthats stimulating change. This will enhancenational acceptance and market penetration ofthe proposed model. In the United Kingdom, theposition dictates the level of competency needed

    to practice whereas the proposed frameworkwould allow the individual pharmacist totransition through the levels of practice as theygain experience or develop their practice. Theproposed model is also fundamentally similar tot he c re de nt ia li ng f ra me wo rk re ce nt lyrecommended by the CPP that delineatescredentials based on practice domain (e.g.,system-wide vs. patient focused), practice focus(e.g., generalist vs. population specific), and theacq u ir ed levels o f kn o wledge, ski l ls, an dexperiences (e.g., entry level vs. advanced).74

    Both models are aligned with the ability andpractice-based outcomes used by ACPE to assesseducational curricula.4 The CPP framework,however, incorporates only currently availablecredentials, most of which are knowledge basedand limited to specific patient populations.Under the CPP model, credentials are notcurrently available for pharmacists wishing toprovide advanced services to critically illpatients. By incorporating a portfolio reviewcomponent, the proposed model provides anddefines opportunities for the demonstration and

    assessment of skills and experiences.The proposed model recognizes skill sets

    beyond knowledge (e.g., communication,leadership, management, education/trainingdevelo pmen t, an d r esearch / evalu atio nmentoring, education, committee participation,project management / scholarship). The level ofservice at which a pharmacist is assessed willdepend upon the training background andexperience of the pharmacist as well as thepr actice settin g an d r equ iremen ts o f th einstitution. This method of credentialing would

    provide opportunities for the established

    pharmacist without advanced training todemonstrate competencies necessary to performhigher level services. It provides all pharmacistswith the opportunity to progress to providinghigher levels of services and credentials. This isespecially pertinent because it maximizes

    professional acceptance of the credentialingpr o cess, ex pan ds th e mar ket deman d fo rcredentialing, and provides a means to limitprofessional fragmentation that occurs withvarious training and experiential backgrounds. Italso provides systematic structure to the processof credentialing that is easily interpreted byadministrators and other healthcare providers.This system would advance the concept of thec ri t ic al c a re p ha rm ac y m en to r s o t he s eopportunities are available to trainees andpromote continuous learning as pharmacists

    would be required to maintain or achieve variouslevels of credentials.

    Limitations exist to this model. Practically,implementation would be difficult and costly.Many professional organizations, governmentalagencies, pharmacy schools, residency programs,acute care institutions, and payers would need top ar tn er. D es c ri pt i on s o f c o mp e te nc ie s ,submission guidelines and timeframe, panels ofexperts and mentors, and an appeals processwould need to be established. It is anticipatedthat some of the costs of administering the

    program would be supplemented by governmentor educational programs and possibly payers.However, the individual pharmacist or employerwo uld l ikely pay an assessmen t fee. I t isenvisioned that achieving and maintainingdesirable or optimal skills in accordance with thismodel may encompass prescribing privilegesa nd /o r e s ta b li s h a m et ho d f o r f i na nc ia lreimbursement for pharmacy services. Accord-ingly, a nominal fee for the purpose of acquiringthese credentials may be offset by the potential togenerate revenue. It is, therefore, incumbent on

    the pharmacy profession to demonstrate thatpharmacy services are associated with positiveoutcomes and/or cost-effectiveness and thatassessment of these services may be incorporatedinto a credentialing model.75

    Documenting and Justifying Critical CarePharmacy Services

    The documentation of services provided bycritical care pharmacy practitioners shoulddemonstrate the diversity, effectiveness, cost, and

    o u tco mes o f th e activit ies per fo rmed. I n

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    addition, documentation may demonstrate coreskill sets required for competency assessmentsan d/o r cr edential ing. N ear ly 9 3 % o f I C Upharmacists document their services but most ofthese services are fundamental.2 About 75% ofd o cu me nt a ti o n p ro g ra ms t r ac k c l in ic al

    significance but only 22% attach an economicimpact. Most documentation programs are eitherpaper-based or use a centralized computer whilefar fewer use a decentralized system (e.g., hand-held/laptop computer). It is anticipated thatdocumentation may lead to justification andincreased funding of additional and/or higherlevel activities, thereby expanding the pharmacyservices provided, matching the growth of ICUbeds, and meeting the demands of the criticalcare profession. This portion of the documentwill focus on the elements of documentation for

    the various levels of pharmacy services, developtemplates for documentation, and providerecommendations for service justification.Information is presented in general terms usingcritical care pharmacy as an example that mayserve as a template for the profession.

    Elements of documentation

    O ppo r tu n ities to do cument an d ju sti fypharmacy services in the ICU are vast andi nc lu de i nc re as e d p at ie nt e x po s ur e t o

    medications, complex therapeutic regimens,rapidly altering patient-specific variables (e.g.,organ function, pharmacokinetic profiles, etc.),costly medication regimens, therapeutic regimenswith specific use criteria, safety, constantlyemerging data, and greater interactions withother healthcare providers. The method andservices documented, however, will depend onth e levels o f ser vices pr o vided, I C U an dpharmacy structures, and available hospitalsupport systems (e.g., information technology).As the level of pharmacy services progress, the

    functions of the pharmacists evolve fromidentification and resolution to prevention andmanagement of a particular issue. As a result, theinterventional target, documented skills andoutcomes, and reasons for justification will alsoexpand as the level of services advance. Table 5outlines how the process of documentation maydiffer according to the levels of pharmacyservices.

    Pharmacists providing fundamental servicesare involved in order processing more than directpatient care.1, 14 As a result, they act to identify

    and resolve issues that are usually directed at a

    p ar ti cu la r m ed ic a ti o n o r p a ti en t. T he i rinterventions usually occur at the time of orderverification and tend to be retrospective relativeto when the order was written. The process ofidentification may be prospective if thesepharmacists perform patient profile reviews.

    These pharmacists usually resolve issues byc om mu ni ca ti ng w it h o th er h ea lt hc areprofessionals or directing therapy under theguidance of ICU or hospital-wide protocols orpolicies (e.g., automatic substitution, IV to POc on ve rs io n, m ed ic at io n re st ri ct io ns ,pharmacokinetic service, etc.). Activities thatoccur frequently and require documentation byth ese ph ar macists in clu de avo idance o rresolution of drug-related problems, clinicalinterventions, therapeutic monitoring, andm ed ic at io n o r a dm in is tr at io n re la te d

    information. The most common interventionsdocumented are order verification and entry,drug distribution, and drug information.Appendix 1 provides a template of a paper-baseddo cumentatio n fo r m th at captu res th eserequirements. Alternatively, some institutionsand pharmacists may use computer-baseddocumentation methods that may involve pop-ups c re e ns i nc or po r at e d i nt o t he h os p it alinf ormat ion s ys te m or independe ntdocumentation systems. Systems that are alignedwith the hospital information system have the

    benefit of synching with the pharmacy orlaboratory databases and may be accessed byothers to generate reports. Of note, users spendless time and tend to prefer computerizedsystems over paper-based manual methods. Staffp ha rm ac i st s , h ow ev e r, d o cu me nt m or einterventions when using a manual method.89, 90

    The physical location of these pharmacists alsoalters the activities documented. Pharmacistsworking in a centrally located area are morelikely to provide information regarding producti de nt i fi c at i on a nd a v ai la b il i ty w he re as

    pharmacists practicing in an ICU-related(satellite) location are more likely to provideservices such as therapeutic monitoring andinterventions, education inservices, CPRparticipation, project management and clinicalresearch endeavors, and information regardingmedication administration and compatibility.89, 90

    These pharmacists also receive more inquiriesa nd t e nd t o i nt e ra ct d ir ec t ly w it h o t he rhealthcare professionals. The use of clinicaldecision support software (e.g., computerizedprescriber order entry) also changes the type of

    interventions as some order errors are reduced

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    (e.g., incomplete orders, wrong dose or fre-quency) but other issues emerge (e.g., incon-sistent orders, unnecessary orders, orders notaligned with ICU guidelines, etc.) necessitating

    i nt er v en ti o n a nd d oc um en ta t io n b y t hepharmacist.9093

    In order to maximize documentation, usersshould be provided an opportunity to give

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    Table 5. Elements of Documentation Relative to the Level of Pharmacy Services.

    Required RequiredDocumentation Skills to be Outcomes Audience /

    Level of Service Method Function Target Focus Documented Attached Justification

    Fundamental Paper-based or Identify Patient Avoidance or Cost Self (primarily order computer-based Resolve Medication resolution of drug- Number of Pharmacyprocessing) (pop-up screens, related problems interventions department

    possible health Clinical Intervention Accrediting agenciessystem integration) interventions outcome

    Therapeutic Potentiallymonitoring include:Medication or Medicationadministration safetyinformation MedicationMedication appropriatenessreconciliation ClinicalPotentially significanceinclude: TimeEducation commitmentof other Resourceprofessionals utilization

    Patient profilereviewsCPR responseCommitteeparticipationResearchinvolvement

    Desirable Should be Identify Patient Must include: Must include: Self (mixed order computer-based R esolve Medication Avoidance or Cost Pharmacyprocessing/clinical Solve Disease state resolution Number of departmentor clinical Prevent of drug-related interventions ICU service orbut not ICU problems Intervention departmentspecialist) Clinical outcome Pharmacy and

    interventions Medication ICU peers

    Therapeutic safety Hospitalmonitoring Medication administrationMedication or appropriateness Affiliated universityadministration Clinical Accrediting agenciesinformation significanceMedication Timereconciliation commitmentEducation of Resourceother utilizationprofessionals PotentiallyEducation of include:patient Therapyor family outcomePatient profile (e.g. analgesia orreviews sedation levels)

    CPR response Cost of outcomeCommittee Patient outcomeparticipation Length of stayResearchinvolvement

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    feedback about the various methods and systemsprior to implementing a documentation system.The documentation program must mesh with thepharmacists responsibilities without creatingburdensome duties that contribute to additionalworkload. Pharmacists starting a documentationprogram should consider whether efficiency ismaximized by implementing a comprehensiveprogram (e.g., Appendix 1) or focusing theprogram so that it captures the sickest patients orcertain medications such as those highlighted byTJC as patient safety initiatives22 or those knownto cause the most serious adverse events (e.g.,vasoactive agents, sedatives/an algesics,electrolytes, anticoagulants, insulin).4554, 93, 94

    Another consideration is the method that will beused to compile the documented information.Interventions may be classified by type, targetmedication, hospital unit / patient population,time of day (or shift-based), interventionoutcome (solved vs. unresolved), patiento ut c om e, c l in ic al s i gn if ic a nc e, c o st o f intervention, time commitment, or pharmacist.

    Pharmacists providing desirable servicesshould have substantial responsibilities forclinical services that involve direct patient care.1, 7

    Many of these pharmacists are responsible forservicing several patient care populations and/orhave order processing duties incorporated as af unc ti on o f t he ir d ire ct p at ie nt c are

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    Table 5. (continued)

    Required RequiredDocumentation Skills to be Outcomes Audience /

    Level of Service Method Function Target Focus Documented Attached Justification

    Optimal Computer-based Identify Patient If needed, must Must include: Self (ICU clinical or minimal Solve Medication include: Cost Pharmacyspecialist or documentation Prevent Disease state Avoidance or Number of departmentclinical as service is Manage ICU patient resolution interventions ICU service oradministrator) recognized and Guide care of drug-related Intervention department

    justified Educate problems outcome Pharmacy andResearch Clinical Medication safety ICU peers

    interventions Medication HospitalTherapeutic appropriateness administration

    monitoring Clinical Affiliated universityMedication or significance Accrediting agencies

    administration Time commitment Publicinformation Resource Payer

    Medication utilization Government agencyreconciliation Therapy outcome Licensing body

    Education of other (e.g. analgesia or Granting agencyprofessionals sedation levels)

    Education of Cost of outcomepatient Patient outcomeor family Patient disposition /

    Patient profile length of stayreviews Patient readmission

    CPR response Potentially include:Committee Satisfactionparticipation assessmentsResearch by patients,involvement families, or otherPotentially ICU professionals

    include: Peer reviewProcess of care MentoringVerbal Process assessmentscommunication Risk reduction

    Written Publicationcommunication Statistical interpretationLeadership Prescriber privilegesManagement Return on investmentSelf reflection Service reimbursement

    CPR=cardiopulmonary resuscitation; ICU=intensive care unit

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    responsibilities in the ICU. In addition totargeting specific medications or patients, thesepharmacists tend to be involved in managingdisease states either at the bedside as part of thepatient care team or through the development ofprotocols and guidelines. These pharmacists

    should strive to identify and resolve issuesprospectively and progress toward solving andpreventing problems. Like those providingfundamental services, documentation will focuson the most common interventions but shouldinclude educational services provided to otherhealthcare professionals, patients, and familymembers; patient profile reviews; CPR response;committee participation; quality improvementin itiatives; an d pro ject management an dscholarly activities. As a result, the outcomesattached to documentation will expand upon

    those documented for fundamental services toinclude assessments of therapy outcome, cost ofoutcomes, patient outcomes, and possibly lengthof stay in the ICU. A computer-based system isthe preferred method of documentation. Thissystem must be