Presentation on theme: "Robert L. Maher Jr., Pharm.D, BCPS, CGP"— Presentation transcript:
1 Robert L. Maher Jr., Pharm.D, BCPS, CGP F-Tag 428 Medication Regimen Review Drug Use Problems in Long Term Care Residents and Key Elements to Performing a Drug Regimen ReviewRobert L. Maher Jr., Pharm.D, BCPS, CGPAssistant Professor of Clinical PharmacyDuquesne University School of PharmacyVice-President of Clinical ServicesMission Pharmacy ServicesOctober 26th , 2007
2 Timeline for Pharmacy Tags Reminder: Appendix N Deleted - Effective June 2004Effective date/implementation scheduled for DECEMBER 18, 2006
3 Tags Combined Pharmaceutical Services New Tag F428 = Old Tags F428, F429, F430DRR/MRR
4 F428 - MRR RegulationsThe drug regimen of each resident must be reviewed at least once a month by a licensed pharmacistThe pharmacist must report any irregularities to the attending physician and the director of nursingAnd, these reports must be acted upon
5 MRR - What does it say currently? More Frequent ReviewsWeekly Reviews depending on the resident’s condition and the drugs they are takingHigh Risk ResidentsDrug Therapy With High Potential for Less Severe Adverse Outcomes In Persons Over 65 (AKA: Beers list)NoteReview by the surveyor is not necessary for drug therapy given the first seven consecutive days upon admission/readmission, unless there is an immediate threat to health and safety
6 MRR - What does it say currently? The director of nursing and the attending physician are not required to agree with the pharmacist’s report,Nor are they required to provide a rationale for their acceptance or rejection of the reportThey must, however, act upon the reportThis may be accomplished by indicating acceptance or rejection of the report and signing their namesThe facility is encouraged to provide the medical director with a copy of drug regimen review reports and to involve the medical director in reports that have not been acted upon
7 Prior to F-Tag 428The director of nursing and the attending physician are not required to agree with the pharmacist’s report,Nor are they required to provide a rationale for their acceptance or rejection of the reportThey must, however, act upon the reportThis may be accomplished by indicating acceptance or rejection of the report and signing their namesThe facility is encouraged to provide the medical director with a copy of drug regimen review reports and to involve the medical director in reports that have not been acted upon
8 F428 - MRR Definition in glossary: Goal of promoting positive outcomes and minimizing adverse consequences associated with medications;The review includes the following with medication-related problems and med errorsIdentifyingReportingResolvingDone by collaborating with others members of the interdisciplinary team.
9 F428 - MRRWhat are these So “things” we’re preventing, identifying, reporting, and resolving…how are MRPs, med errors, and irregularities defined?
10 F428 - MRR MRPs A Medication-Related Problem (MRP) is: (NOTE HOW SIMILAR THESE ARE TO THE UNNECESSARY MED ‘CATEGORIES’ IN F-TAG 329)Use of a medication without adequate indication for useUse of a medication without identifiable evidence that safer alternatives or more clinically appropriate medications have been considered
11 F428 - MRR MRPsUse of an appropriate medication that is not reaching treatment goals for reasons such as timing or techniques of administration, dosing intervals, etc.Use of a medication in an excessive dose (including duplicate therapy) or for excessive durationPresence of an adverse consequence associated with medication(s)
12 F428 - MRR MRPs Use of a medication without adequate monitoring Inadequate monitoring of response to med, orInadequate response to findings/resultsPresence of or risk for medication errorsPresence of a clinical condition that might warrant initiation of medicationMedication interaction - “TOP 10 DIs in LTC”
13 F428 - MRR Med ErrorsA medication error isn’t actually defined in document, but NCCMERP definition is:“A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.”
14 F428 - MRR Irregularities An irregularity is: “Any event that is inconsistent with usual, proper, accepted, or right approaches to providing pharmaceutical services (as defined by F425), or that impedes or interferes with achieving the intended outcomes of those services.”
15 F428 - MRRGiven those definitions, important to note that document also states:“This guidance is not intended to imply that all adverse consequences related to medications are preventable, but rather to specify that a SYSTEM exists to assure that medication usage is evaluated on an ongoing basis…”
16 F428 - MRR Frequency of Review Monthly or more frequently, depending on:the resident’s condition, andthe risks for adverse consequences related to current medicationsThis sounds alarming, but it is virtually the same as current survey guidelines
17 F428 - MRR Where to Conduct the Review Generally within facility because important info may be attainable only by talking to staff, reviewing “paper” chart, observing/speaking with residentBUT new technology (electronic health records) may permit the PHARMACIST to conduct some components of the review outside of the facility
18 F428 - MRR Sources of Information May include, but are not limited to:MARsPrescribers’ ordersProgress, nursing, consultants’ notesRAI/MDSLab reportsForms/reports reflecting behavioral monitoring and/or changes in conditionQM/QI reportsAttending physician, facility staffInterviewing, assessing, and/or observing the residentAsk yourself, how many of these do I use and should I be using more sources or different types of sources than I am now?
19 F428 - MRR MRR Considerations MRR considers factors, such as:Has MD/staff documented objective findings, diagnoses, symptoms to support indication?Has MD/staff identified and acted upon, or should they be notified about, resident’s allergies, potential interactions/averse consequences?Is dose, frequency, route, duration consistent with resident’s condition, manufacturer’s recommendations, and applicable standards of practice?
20 F428 - MRR MRR Considerations Has MD/staff documented progress towards or maintenance of the goal(s) for medications therapy?Has MD/staff obtained and acted upon lab results, diagnostic studies, or other measurements?Do med errors exist or do circumstances exist that make errors likely to occur?
21 F428 - MRR MRR Considerations Has MD/staff noted and acted upon possible medication-related causes of recent or persistent changes in the resident’s condition?…think “Geriatric Syndromes”Anorexia and/or unplanned weight loss, or weight gainBehavioral changes, unusual behavior patternsBowel function changesConfusion, cognitive decline, worsening of dementiaDehydration, fluid/electrolyte imbalanceDepression, mood disturbanceDysphagia, swallowing difficultyExcessive sedation, insomnia, or sleep disturbance
22 F428 - MRR MRR Considerations Falls, dizziness, impaired coordinationGI bleedingHeadaches, muscle pain, generalized aching/painRash, pruritisSeizure activitySpontaneous or unexplained bleeding, bruisingUnexplained decline in functional statusUrinary retention or incontinence
23 F428 - MRR Notification of Findings Pharmacist is expected to document either that no irregularity was identified or the nature of the irregularity(ies), if any were identifiedIf none, pharmacist would include a signed and dated statement to that effectDifferent iterations of this requirement throughout the various drafts, but final focus is on the use of the word “report” as a verb rather than a noun
24 F428 - MRR Notification of Findings Timeliness of notification depends on potential for or presence of serious adverse consequencesExamples include:Bleeding resident on anticoagulantsPossible allergic reactions to antibioticCollaborate with facility to identify the most effective means of notification/documentationNotification/documentation may be done electronically
25 F428 - MRR Notification of Findings Pharmacist’s findings are part of clinical recordIf not maintained within active clinical record, it must still be maintained within facility and readily availableFind balance between:Encouraging/facilitating other HC professionals to utilizeAllowing facilities flexibility in determining a consistent location that suits their needs
26 F428 - MRR Response to Findings Physician either:Accepts recommendation and acts, ORRejects the recommendation and provides a brief explanation, such as in a dated progress note“It is not acceptable for a physician to document only that he/she disagrees with the report without providing some basis for disagreeing.”For those direct care issues that do not require physician intervention, DON or designated nurse can address and document action taken
27 F428 - MRR Lack of Action or Rejection What about when MD does not act upon or rejects MRR report/recommendations and there is the potential for serious harm?Facility and CP should contact Medical Director, ORWhen attending and MD are same, follow established facility procedure to resolve the situationNo specific timeframe provided for when a report that is not acted upon officially becomes delinquent or “not acted upon”
28 F428 - MRR Lack of Action or Rejection What about continuing to document an issue that the physician has disregarded or rejected?“Pharmacist does not need to document a continuing irregularity each month if it’s deemed to be clinically insignificant or there is evidence of valid clinical reason for rejection”“In these situations, pharmacist need only reconsider annually whether to report again or make new recommendation.”
29 How to sort through all the MRPs in Long Term care
30 Types of Suboptimal Drug Use 1. Overutilization (polypharmacy)2. Underutilization3. Inappropriate utilizationHanlon JT, et al. J Am Geriatr Soc 2001;49:200-9.
31 Total Drug Therapy Cost Control Total Drug Cost $= (Product Cost + Distribution Cost) x Utilization + Medication Related Problems (Therapeutic Failures + ADRS)
33 Performing MRR Familiarize with Medicare and Medicaid requirements Familiarize with recent facility surveysFamiliarize with documentation proceduresFamiliarize with lines of communicationFamiliarize with Medical and Nursing StaffSet dates and times for doing MRR
34 Performing MRR Get to know the following people What reports ADON, DON, Medical Director, Medical RecordsWhat reportsInfection controlRestraintsBehavioralQI Meeting to attendCommittee to involve
35 Performing MRR The Chart Admission Records History and Physical ExaminationPhysician or Prescriber OrdersMARSOmissions (reasons)Prn use – frequency – documented effectNursing Progress NotesHospital Discharge Note - ?? Fax to the pharmacy
36 Performing MRR The Chart Nursing Progress Notes Nursing Staff CommunicationResident ConditionDaily ProgressTreatment PlansVital SignsMonthly SummariesMonitoring of Outcomes of TherapyDocumentation of Adverse EffectsFunctional Ability of ResidentResident Complaints
37 Performing DRR The Chart Physician or Prescriber Progress Notes Diagnosis, Rationale, Therapeutic OutcomesConsultant NotesPsych, Dietary, Social Services, etc..DRR Documentation, Justification of Med useClinical Lab DataUrinalysis, Serum Drug Concentration, CBC, Renal Function test, Thyroid TestTiming of labs
38 Performing MRR Timing of MRR Prospective DRR Upon Admission Target high risk medicationsConcurrent MRRRetrospective MRRDiscontinued medications – question of why??
39 Performing MRR DRR Time Requirements No more than 100 reviews in one dayIndustry standard according to open surveys 9 minutes/chartFactors to considerThe complexity of MRRNumber of Chronic ConditionsMedical Acuity Level of the ResidentDuration of residency in the facilityChronic Care or postacute careThe pharmacist familiarity with a particular resident
40 Targeting the High Risk Elderly Patient Specific MedicationsNTD Renally Cleared MedicationsPhase I metabolized medicationsClass of Medicationsanticonvulants narcotic analgesicsantipsychotics sedative/hypnoticsanticholinergics
41 Targeting the High Risk Elderly Patient Patient’s on Beer’s Criteria DrugsCrCl <50ml/minLow BMI <22kg/m2>6 chronic active medical conditionsPolypharmacy > 9 or more chronic meds
42 Targeting the High Risk Elderly Patient Prior history of an adverse drug reactionAdvanced age (>85)Those with a history of non-complianceThose recently discharged from the hospitalThose with certain illness (e.g. dementia)
43 Preventing ADRs in the Elderly 28% - 56% or ADEs are preventableMost ADEs result from errors in order writing78% are due to “systems failure”Improve information systems when ordering medsIncrease patient educationSystematic review of medicationsDUE and DUR
44 Principles for Optimizing Drug Use in the Elderly Consider whether drug therapy is necessaryPromote the use of a small number of drugs to treat common problemsAdjust doses and or/dosage intervals for medicationsEstablish reasonable therapeutic endpoints and monitor for desired outcomeMonitor for adverse drug reactionsRegularly review the need for chronic medications
45 Chronic Medication Review Steps Assess whether ADRs are the cause of any symptomsMatch problem list with drug listIf on drug but no match with problem list consider whether drug is necessaryIf has a chronic condition and not on a medication consider whether there is an evidence based drug to tx the conditionAssess the monitoring for efficacy/safety/appropriateness of the remaining medications
46 Assessing Prescribing Appropriateness Using the Medication Appropriateness Index Is there an indication for the drug?Is the medication effective for this condition?Is the dosage correct?Are the directions correct?Are the directions practical?Are there clinically significant drug-drug interactions?Are there clinically significant drug-disease interactions?Is there unnecessary duplications of drugs?Is the duration of therapy acceptable?Is this drug on the formulary or the least expensive alternative compared to others of equal utility?(Hanlon, et al)
48 CMS Drug-Drug Interactions Drug Effected Precipitant Drug (s)ASA NSAIDsACE-I K supplements, K sparing diureticsAnticholinergic AnticholinergicAntihypertensives levodopa, nitratesAntiplatelet NSAIDCNS med CNS medDigoxin amiodarone, verapamilLithium ACEI, thiazide diuretics, NSAIDsMeperidine MAOIPhenytoin imidazolesQuinolones Type IA,C, II antiarrhythmicsSSRI tramadol, st john wortSulfonylureas imidazolesTheophylline imidazoles, quinolones, barbituratesWarfarin amiodarone, NSAIDs, sulfonamides, macrolides, quinolones, phenytoin, imidazoles
49 Lindblad C, Hanlon J et al. Clin Ther 2006 (in press) Clinically Important Drug-Disease Interactions Determined by Expert Panel ConsensusDrug DiseaseAlpha blockers SyncopeAnticholinergics BPH, constipation, dementia, glaucoma (narrow angle)Aspirin PUDBarbiturates DementiaBenzodiazepines Dementia, fallsBupropion SeizuresCCB 1st generation CHF (systolic dysfunction)Corticosteroids DMDigoxin Heart blockLindblad C, Hanlon J et al. Clin Ther 2006 (in press)
50 Lindblad C, Hanlon J et al. Clin Ther 2006 (in press) Clinically Important Drug-Disease Interactions Determined by Expert Panel ConsensusDrug DiseaseMetoclopramide Parkinson’s diseaseNon-aspirin NSAIDs CRF, PUDOpioid analgesics ConstipationSedative/hypnotics FallsThioridazine Postural hypotensionTricyclic antidepressants BPH, constipationdementia, falls, heart blockpostural hypotensionTypical antipsychotics FallsLindblad C, Hanlon J et al. Clin Ther 2006 (in press)
51 Overutilization (Polypharmacy) in the Elderly Polypharmacy defined as :1. Concomitant use of multiple drugs2. Use of more medications than areclinically indicated
52 Risks Associated with Polypharmacy Functional status declineADRsInappropriate drug useIncreased medication administration errorsIncreased risk of geriatric syndromes
53 Underutilization of Medication Undiagnosed and untreated condition (e.g., depression)Diagnosed condition but omitted treatment (e.g., post-MI)Underuse of preventive treatment (e.g., vaccinations)One study found that 50% of 372 vulnerable adults not prescribed an indicated medication; Biggest problems with no gastroprotective agent for high risk NSAID users, no ACE-I in diabetics with proteinuria, no calcium\Vit. D for those with osteoporosis(Higashi T et al. Ann Intern Med 2004;140:714-20)Another study found that between 38-76% of assisted living residents had medication undertreatment; Biggest problems with no ASA or beta blocker post MI; non ACE-I in CHF patients; and no calcium\Vit. D for those with osteoporosis(Sloane PD et al. Arch Int Med 2004;164: )
54 Inappropriate Prescribing Prescribing of medications that does not agree with accepted medical standards
55 The I’s of Geriatrics and MRPs ImmobilityIsolationIncontinenceInfectionInanitionImpactionImpaired sensesInstabilityIntellectual ImpairmentImpotenceImmunodeficiencyInsomniaIatrogenesis
56 Medications with Anticholinergic Activity Anti-emetics/anti-vertigo and - (e.g. meclizine)Antiparkinsonians - (e.g. trihexyphenidyl)Antispasmodics- (e.g. belladonna, oxybutynin)Cold and allergy drugs- (e.g hydroxyzine)Sleep aids- (e.g. diphenhydramine)Skeletal muscle relaxants - (e.g. cyclobenzaprine)
57 Psychotropic Drug Use in LTC* Medication Class% LTC Residents UsingAntipsychotics21.1%Anxiolytics15.3%Hypnotics4.3%Anti-depressants47.0%Considered polypharmacy because need for these drugs for behavior management in NH is controversial.Study by Gurwitz found that most medication-related problems occurred with use of antipsychotics > antibiotics > antidepressants > hypnotics*Reflects % of residents with any use of drug type within 7 days prior to MDS assessment.CMS data, 1st quarter, 2006,
58 Risk of Medications for In-Hospital Delirium in the Elderly Drug Class Adj. OR % CI* Final ModelNeuroleptics * ( )*Narcotics ( )*H2 BlockerDigoxin *AnticholinBenzodiaz *SteroidNSAIDp<0.05Schor JD et al. JAMA 1992;267:
59 Communication Consultant Pharmacist Communication Techniques Meet your physiciansWhat is the best type of communication?When do the physicians make rounds?Type written vs hand written recommendations
60 Communication What physicians say they want from pharmacists Recommendations designed to achieve improved efficacy and decreased risk of adverse drug reactionsHelp in reducing unnecessary drug useInformation about drug side effects and interactions
61 Communication What physicians say they want from pharmacists Medication-related information and in-services for facility staffMonitoring and dosing of Narrow therapeutic drugsHelp in developing processes for detecting and reporting adverse drug reactionsPerformance of drug regimen review as close as possible to point of prescribing
62 CommunicationMany physicians feel it is the content that is lacking in recommendations from pharmacistsPhysician Pet PeevesRecommending changes from computer generated pharmacy profilesClosing the saleCommunicate the solving of the problem not the perception of the problem.Communicating the regulatory issues and addressing the true patient concerns.
63 Communication To Cite or Not to Cite Refer to guidelines and the medical literature, make sure it is relative to the elderly resident.What if the physician does not respond?Follow the paper trailAre they being sent back in a timely mannerMeet with the medical director and create a good professional relationshipMaintain a presence in the facility.Choice of words is always a plus
64 Communication Consultant Software Communication examples In-house pharmacy reporting examples