Objectives. Medication Reconciliation. Safety Net or False Sense of Security? REBECCA B. SLEEPER, PHARM.D, FCCP, FASCP, BCPS

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1 Medication Reconciliation: Safety Net or False Sense of Security? REBECCA B. SLEEPER, PHARM.D, FCCP, FASCP, BCPS Objectives During or after a transition of care: Distinguish which medication reconciliation practices do, or do not, translate to improved medication outcomes in the next venue of care Identify EMR documentation and order entry behaviors that influence the accuracy of medication data Evaluate the predictive value of medication appropriateness tools for identifying patients at risk for experiencing an adverse medication outcome Medication Reconciliation What is it? Essentially, a comparison between home list to hospital list to discharge list. Per the Joint Commission 2 part requirement: NPSG No. 8A: a process must exist for comparing the patient s current medications with those ordered for the patient while under the care of the organization NPSG No. 8B: a complete list of the patient s medications must be communicated to the next provider of service on transfer within or outside the organization and a complete list of medications must be provided to the patient on discharge In executing this task: Operating definition of what is a medication is not universal Individual responsible for obtaining information and performing steps is not specified Joint Commission on Accreditation of Healthcare Organizations Hospital Accreditation Standards, p. NPSG 4. Greenwald JL, et al. Journal of Hospital Medicine 2010;5(8):

2 What happens when medication list is assumed to be interchangeable with medication history? The interpretation drives what kind of data is collected and shared. Will it be a list of: Prescription medications? Both scheduled and as needed prescription medications? Both scheduled and as needed prescription medications, plus over the counter (OTC) medications? Both scheduled and as needed prescription medications, plus OTC medications and all supplements and alternative/complimentary products? What happens when medication list is assumed to be interchangeable with medication history? Medication list with formulation info? Medication list with formulation info and prescribed dose? Medication list with formulation info and prescribed dose and interval? Medication list with formulation info and prescribed dose and interval and history of who prescribed or when initiated? Medication list with formulation info and prescribed dose and interval and history of who prescribed or when initiated with desired duration of therapy? Medication list with formulation info and prescribed dose and interval and history of who prescribed or when initiated with desired duration of therapy and data about whether/how the patient is actually taking it? Medication list with formulation info and prescribed dose and interval and history of who prescribed or when initiated with desired duration of therapy and data about whether/how the patient is actually taking it, and what kinds of outcomes the patient has experienced/achieved with each product? Medication information accompanied by intended reason for use? Concept of Medication Appropriateness What do we want from optimal drug therapy? THIS ALSO MEANS ENSURING: Right drug Right reason Right patient Right strength/formulation Right dose Right interval Right technique Right duration Proper adherence or persistence Reasonable cost Avoidance of adverse effects Avoidance of contraindications, drug drug or drug disease interactions Appropriate monitoring, oversight, and periodic reassessment at the proper intervals to evaluate dose or duration of therapy Both health care providers and patient agree that the drug is achieving the intended outcome Adjustments are made when this does not occur 2

3 One source of truth Institute for HealthCare Improvement endorses a Medication Reconciliation toolkit to ensure best practices Once source goal is to eliminate confusion of conflicting records sources Still focuses on the medication list itself patient safety/patient safety resources/resources/match/matchfig3.html Medication Related Problems (MRP) detected by Basic Medication Reconciliation Review of a single medication list: Number of products Drug interactions Explicit criteria violations Comparison of one list to another list: Duplications Omissions Transcription errors If the goal is medication safety, don t we need a system that can detect all the ways in which medication therapy can go wrong? Concept of Medication Inappropriateness What are all the ways drug therapy can go wrong? TERMS FOR COMMON MEDICATION RELATED PROBLEMS: Inappropriate medication High risk medication Unnecessary medication Inappropriate medication use Inappropriate prescribing Medication error Medication misadventure Polypharmacy Side effect Adverse drug reaction Adverse drug event Contraindication Interaction (drug drug, drug disease, drugfood ) Toxicity Overdose Medication misuse / abuse Non compliance / non adherence Sub therapeutic dose Untreated indication Withdrawal Therapeutic failure Therapeutic duplication Prescribing cascade 3

4 Others terms / considerations used to qualify medication related problems Is the outcome suspected, confirmed or merely likely? Possible, potential, near miss Is the evaluation prospective or retrospective? Who is the target audience or participant? The patient? A patient population? The informal caregiver? The health professional? If so, which profession(s)? The Health system? If so, what setting or context? Alphabet soup MRP ADR ADE AE IM IP PIM PIP PIPE OMG! Medication related problem Adverse drug reaction Adverse drug event Adverse event Inappropriate medication Inappropriate prescribing Potentially inappropriate medication Potentially inappropriate prescribing Potentially inappropriate prescribing in the elderly Sorting through the jargon Why these terms are not interchangeable Each describes a different problem Each has a different etiology, with distinct risk factors and causative factors Why is it important to make Distinctions between terms? Each problem likely requires its own solution Conflation of terms makes it difficult to perform a literature search OR make solid (statistically supported) conclusions about prevalence or consequences. Makes it difficult to form concrete action plans to: Identify / quantify relevant issues a given institutional setting Implement specific action plans for quality improvement 4

5 Examples Adverse drug reaction (ADR) Implies an unwanted outcome that is specifically related to a drug s pharmacology of mechanism of action e.g. opiate analgesics causing constipation Adverse drug event (ADE) Implies any unwanted outcome involving medication use. Can include ADR s but also medication errors, interactions, overdose, non adherence, therapeutic failure, withdrawal Examples Inappropriate medication/drug Implies some aspect of the medication (it s pharmacology, mechanism of action or effects) makes it a poor choice Must be qualified by context specifics Inappropriate prescribing Implies a behavior by a specific subset of health professionals involving the selection or ordering of drug therapy Inappropriate medication/drug use Implies a behavior by any individual involved in the disposition or use of a medication How effective is med rec for addressing these issues? Med rec studies are not aimed to evaluate this Focus: 30 day readmissions ADEs (short term) Difficult to find data evaluating real world med rec practices Lit searches for Medication reconciliation yield publications describing med rec structures or promoting the need for med rec Narrowed searches for studies about Med rec efficacy are often published for a pharmacy audience Pharmacist led medication reconciliation often involves enhanced intervention services beyond just medication list comparisons 5

6 How does medication reconciliation support the next care environment? Ensing HT, et al. J Clin Pharm Ther 2016 Dec 10. doi: /jcpt Urban R, et al. Int J Clin Pharm 2013 Oct;35(5): doi: /s Kennelty KA, et al. Res Social Adm Pharm 2015 Jul Aug;11(4): doi: /j.sapharm Using a checklist to evaluate post discharge prescriptions across 44 outpatient pharmacies, 92% of Rx required intervention (31% medication discrepancies, 34% administrative problems, 35% patient lack of understanding) Survey of 14 community pharmacies about information received from hospital post discharge. Results indicate data shared is inconsistent or lacking. If provided, usually limited to contexts where patients were receiving medications in monitored dosage systems. Survey to identify barriers to med rec on the community pharmacy end. Barriers cited include lack of discharge communication and limited resources to overcome gaps in information. Suggested facilitators included providing pharmacy with fill hospital discharge list with stop orders for discontinued medications. Long term care Retrospective review of 1500 medication orders in long term care facility Medication compared to the documented indication for use in the ICD 9 field of the electronic order 30% of medication orders were associated with an ICD 9 code that was not related to the medication Examples: Risperal/allergic rhinitis, docusate sodium/hip fracture Inability to assess medication appropriateness or make specific recommendations to alter therapy when medication s purpose or intended duration is ambiguous. Sleeper RB, Pham Smith L. Workarounds in the medication reconciliation and order entry process in a long term care facility. Paper presented at the American Society of Consultant Pharmacists Annual Meeting, 2013; Seattle, WA How does this reflect pharmacy services? Structured interview survey of pharmacists reveal that pharmacists believe that med rec is on of the most important roles provided in transitions in care. Cite the need for clearer communication by team, protected time, enhanced patient and family engagement, and more resources for provision of educational materials Haynes KT et al. Ann Pharmacother 2012 Sep;46(9): doi: /aph.1Q641. 6

7 How does this reflect pharmacy services? A national survey of US facilities focused on transition of care activities Only 27% of respondents indicated that pharmacists complete medication histories (56% done by nurses, 11% by physicians) Only 12% indicated that pharmacists complete admission medication reconciliation in the emergency department At discharge, the % reporting a pharmacist participation in the following activities were: 24% counseling, 22% in discharge med rec, 10% in the provision of adherence aids and 2% (each) in the participation of communication with outpatient pharmacy, communication with physician, or patient follow up after discharge By contrast 44% reported that pharmacists are not involved with transitions of care activities at discharge Does pharmacist led med rec fare better? IPITCH study Pharmacist involvement in Med Rec, patient education, and postdischarge call backs 30 day readmissions: 39% control arm, 24.8% study arm (p=0.01) ADEs 12.8% control arm, 8% study arm (p>0.05) Meta analysis of 17 studies from including 21,342 adult patients None of the interventions used Med Rec alone. All used some kind of enhanced intervention Patient counseling, telephone follow up, coordination with outpatient providers, other types of structured medication review/monitoring Next slides Phatak A et al. J Hosp Med Jan;11(1): doi: /jhm Mekonnen AB et al. BMJ Open 2016;6:e doi: /bmjopen Mekonnen AB et al. BMJ Open 2016;6:e doi: /bmjopen

8 Mekonnen AB et al. BMJ Open 2016;6:e doi: /bmjopen Mekonnen AB et al. BMJ Open 2016;6:e doi: /bmjopen Mekonnen AB et al. BMJ Open 2016;6:e doi: /bmjopen

9 So how do we measure what we want to look at? Several tools have been developed to identify inappropriate medications It is important to distinguish exactly what they identify Types of tools Indicators, Explicit criteria, Implicit criteria Indicators Refers to a characteristic that suggests a high potential for a medication related problem Example: Polypharmacy Utility of indicators as a determinant of appropriateness Polypharmacy Multiple definitions Some based on numerical criteria (more than 9, more than 5 ) Strictest numerical definitions identify any regimen of more than 1 drug as polypharmacy Some based on qualifiers such as whether meds are necessary (medications without documented indication, therapeutic duplications) 9

10 Variation in definition affects utility of the indicator Numerical criteria correlate to the potential for drug drug interactions Increased risk with 4 5 medications, risk approaches 100% with 9 or more medications Some correlation with numerical criteria and specific adverse outcome: 4 5 medications more associated with drug induced cognitive impairment than 0 1 medications. Does not address all aspects of appropriateness Depending on the disease state, multiple medications may not only appropriate but very necessary (e.g. heart failure) Variation in definition affects utility of the indicator Unnecessary or duplicative prescribing can occur regardless of the overall number of drugs on the regimen (even 1 drug can be unnecessary) These concepts focus on very different types of health systems problems (poor prescribing vs poor medical records documentation or poor transcription behaviors) Utility of the term Polypharmacy Polypharmacy using a numerical criterion works as an indicator if the objective is to identify individuals at risk for drug drug interaction Still have to evaluate the clinical significance of interactions identified Polypharmacy may or may not be the most descriptive term to employ if the goal is to target unnecessary or duplicative medications. Various definitions of Polypharmacy have epidemiological value, because it can be used to identify and describe medication use patterns and behaviors Polypharmacy would not be a good choice around which to design medication intervention It really isn t fully assessing appropriateness There is great risk of false negatives and false positives. Medication reduction or discontinuation could lead to adverse drug withdrawal events 10

11 Explicit criteria Finite lists of specific medications adjudicated to be problematic appropriateness is determined based on whether a patient is prescribed a medication from this list or not. Beers list Beers MH, Ouslander JG, Rollingher I, Reuben DB, Brooks J, Beck JC; UCLA Division of Geriatric Medicine. Explicit criteria for determining inappropriate medication use in nursing home residents. Arch Intern Med. 1991;151(9): Beers MH Explicit criteria for determining potentially inappropriate medication use by the elderly. Arch Intern Med. 1997; Fick DM et al. Updating the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults Results of a US Consensus Panel of Experts Arch Intern Med. 2003;163(22): doi: /archinte American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2012;60(4): American Geriatrics Society 2015 Updated Beers Criteria for potentially inappropriate medication use in older adults. Expert Panel American Geriatrics Society J Am Geriatr Soc 2015;63: Start / STOPP criteria O Mahony D, Gallagher P, Ryan C, et al. START & STOPP criteria: A new approach to detecting potentially inappropriate prescribing in old age. European Geriatric Medicine 2010;1(1):45 51 Barry P. J., Gallagher P, Ryan C. et al. START (screening tool to alert doctors to the right treatment) an evidencebased screening tool to detect prescribing omissions in elderly patientsage and Ageing 2007;36: Gallagher P, O Mahony D. STOPP (Screening Tool of Older Persons potentially inappropriate Prescriptions): application to acutely ill elderly patients and comparison with Beers criteria Age and Ageing 2008;37: Evolution of Explicit Criteria Beers list: versions (United States) Naughty list Updated to differentiate independent of diagnosis and considering diagnosis (but still a naughty list) Enter START / STOPP: (Europe) Updated approach to include drug interactions and more nuanced contexts in which medications (that may be other wise appropriate) become inappropriate: STOPP list (but still a naughty list) Updated to address common omissions: START list Beers list: versions (United States, American Geriatrics Society) Restructuring, deletion of outdated medications, addition of new Updated again to include dose adjustments based on renal dysfunction and interactions Right drug Explicit criteria is fundamentally focused on the concept of right drug (either starting the right drug or avoiding the wrong drug ). Right drug is largely a consideration based on pharmacology / mechanism of action, relating to potential for adverse effects or interactions Although with updated criteria there has been the addition of considerations for dose or duration, these are limited to select contexts 11

12 Implicit criteria Set of weighted considerations applied to a drug or list of drugs to evaluate appropriateness or relationship of the drug to an outcome Medication Appropriateness Index (MAI) Hanlon JT, Schmader KE, Samsa GP, et al. A method for assessing drug therapy appropriateness. J Clin Epidemiol 1992;45: Spinewine A, Dumont C, Mallet L, Swine C. Medication appropriateness index: reliability and ecommendations for future use. J Am Geriatr Soc. 2006;54: Naranjo causality assessment Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2): Items included on the MAI Criteria Weight factor Are there significant drug drug interactions? 2 Are there significant drug disease interactions? 2 Is there an indication for the drug? 3 Is the drug effective for the indication? 3 Is there unnecessary duplication with other drugs? 1 Is the duration of therapy acceptable? 1 Is the dosage correct? 2 Are the directions correct? 2 Are the directions practical? 1 Is this drug the least expensive alternative compared to others of equal utility? 1 Naranjo ADR items and scoring Question Yes No Don t know Are there previous conclusion reports on this reaction? Did the adverse event appear after the suspect drug was administered? Did the AR improve when the drug was discontinued or a specific antagonist was administered? Did the AR reappear when drug was re administered? Are there alternate causes [other than the drug] that could solely have caused the reaction? Did the reaction reappear when a placebo was given? Was the drug detected in the blood [or other fluids] in a concentration known to be toxic? Was the reaction more severe when the dose was increased or less severe when the dose was decreased? Did the patient have a similar reaction to the same or similar drugs in any previous exposure? Was the adverse event confirmed by objective evidence? >9 = definite ADR; 5 8 = probable ADR; 1 4 = possible ADR; 0 = doubtful ADR 12

13 Utility of Explicit Criteria as a determinant of appropriateness Benefits of explicit criteria Easy, even a lay person can use them Fast, can quickly scan/compare the list to a med regimen or data set of medication orders Drawbacks to explicit criteria Finite (or, not exhaustive ) lists that can quickly become out of date A drug s presence on the list is based primarily upon its pharmacology (MOA) Potential for the drug s MOA to result in side effects Delphi methodology required panel of experts to achieve 90% agreement that a drug had this potential in order for it to make the list Evidence base support that risks of medication outweigh benefits Example of drugs not making the list: warfarin, insulin Predictive value for identifying patients who will experience ADRs or ADEs Chang CB et al. Drugs and Aging 2010; 27(12): Corsonello A et al. JAGS 2009;57 (6): Page RL et al. Am J Geriatr Pharmacother 2006;4(4): Budnitz D et al. Ann Intern Med 2007;147(11): Levy HB etal. Ann Pharmacother 2010;44: Chang CB et al. Br J Clin Pharmacol. 2011;72(3):482 9 Explicit criteria shows limited predictive value for identifying actual adverse events. Drugs identified by explicit criteria resulted in only 6 9% of ADR s among hospitalized elders, and among emergency room admissions for medication related events, only 4% were caused by Beer s list drugs. STOPP criteria has been demonstrated to be somewhat better Among emergency hospitalizations for adverse drug events, very few resulted from medications typically considered high risk or inappropriate Budnitz DS et al., N Engl J Med. 2011;365(21): Only 30 40% of medications identified as potentially inappropriate were determined to be result in drug related problems Recommended applicability for explicit criteria Screening Efficacy is likely enhanced if used on concert with other criteria Epidemiology value (just please remember the potentially in potentially appropriate) Not an evaluation tool Do not recommend for punitive purposes. 13

14 Utility of Implicit criteria as a determinant of appropriateness Benefits of implicit criteria Considers multiple dimensions of appropriateness. Really the only kind of tool that evaluates aspects of our 5Rs as well as ease of use, cost, efficacy, etc Drawbacks Cumbersome to apply. Time consuming Requires high degree of medication expertise. Relies on the availability and accuracy of data to answer all questions Historically has been more suited to research than clinical practice. Predictive value of the MAI Schmader KE, et al. Ann Pharmacother. 1997;31: Higher MAI scores were significantly associated with unscheduled ambulatory or emergency department visits, and poor blood pressure control and non significant increase in hospital admission Lund BC, et al. Ann Pharmacother. 2010;44: Hanlon JT, et al. Age Ageing. 2011;40: Olsson IN, et al. Health Qual Life Outcomes. 2011;9:95. Hellstro m LM, et al. Eur J Clin Pharmacol. 2011;67: Somers A, et al. Am J Geriatr Pharmacother. 2012;10: Gillespie UM, et al. Plos One. 2013;8:e Modified MAI scores associated with incidence of adverse events Drug disease interaction criteria predicted adverse drug reactions, Higher MAI scores were significantly associated with lower quality of life as measured by EQ 5D and EQ VAS Higher MAI scores significantly associated with drug related hospital admission Comparison with other tools Steinman MA, et al. Med Care. 2007;45:95 9. Lund BC, et al. Ann Pharmacother. 2011;45: Gallagher PF, et al. Clin Pharmacol Ther. 2011;89: Luo R, et al. J Eval Clin Pract. 2012;18: Identification of problem medications was higher with the MAI compared with the Beers criteria MAI identified inappropriate medications the Beers list did not, but higher MAI scores were associated with concomitant use of Beers criteria drugs, suggesting some correlation between Beers criteria and MAI Improvement in MAI has been used as the outcome measure in a randomized controlled trial of the utility of the STOPP criteria as an educational tool Among medication appropriateness tools, MAI was the most convincing measure of appropriateness, but the most time consuming to perform 14

15 Retrospective utility All tools have some retrospective utility, especially in population research, but Naranjo is exclusively applied retrospectively. Naranjo Causality Assessment is a commonly applied tool to assess causality Some data suggest that application of validated causality assessments are necessary because ADR s may be missed clinically Naranjo assessment applied to patients admitted to emergency department. Among cases identified as ADR related, only 62% had been assessed as medication related by ED physician, and 86% of the ADR s that had been assessed as not medication related were at least moderate in severity. Hohl CM et al. Do emergency physicians attribute drug related emergency department visits to medicationrelated problems? Ann Emerg Med Jun;55(6): Recommended applicability for implicit criteria MAI may be the most useful tool for designing specific programs for evaluating medication regimens and implementing drug therapy changes Actually mimics what a pharmacist does Modified version may be necessary to optimize clinical utility Naranjo assessing the contribution of a drug to suspected ADRs Safety committees, Institutional Review Board Other causes of ADR, ADE, or related hospitalization Lack of safety monitoring resulting in adverse outcome Therapeutic failure Due to non adherence Due to lack of efficacy monitoring Adverse drug withdrawal events Acute withdrawal Exacerbation of the underlying disease state Current tools only partially capture or don t capture this data 15

16 Types of data needed to apply the tools For indicators like polypharmacy, you mainly need: Number of drugs For some definitions of polypharmacy, you d need drug name and medical history / indication data to identify medications without indications or duplications Types of data needed to apply the tools For explicit criteria, you mainly need: The drug name, or the drug list For a few items on these criteria dose is relevant as well To apply the criteria based on disease state considerations you need: The medical history data, to identify drug disease combinations triggered by the list Types of data needed to apply the tools For implicit criteria you need: Medical history Medication indication, including reason for use or goal of therapy for all drugs on the regimen Rx and OTC Dose and regimen details for all drugs on the regimen Start date and desired duration of therapy Other important info Adherence info, monitoring data, efficacy/side effect or other outcomes data, cost 16

17 How do medical records documentation practices support the use of these tools? Are medical / medication history and medication reconciliation processes optimal? Is the med list current? Is it accurate? Does the med list contain doses and all regimen details? Medication / indication mismatch data Are the intended indications for each medication known? Is there a single, complete diagnosis list from which this information can be gleaned? Medication reconciliation Is med rec simply a comparison of med lists? Are there enhanced Med Rec practices that incorporate Medication History taking, adherence assessments, supporting diagnosis data, prescribers associated with various therapies, and intended durations? Case examples 66 year old male with heart failure, hypercholesterolemia, and type 2 Diabetes mellitus, medications include: Lisinopril 20mg QD, metoprolol 50mg BID, digoxin 0.125mg QD, furosemide 40mg QD, KCl 20mEq QD, aspirin 81mg QD, pravastatin 40mg QD, glargine insulin 30U HS, regular insulin 4U TID with meals Current status stable Asymptomatic, no recent hospitalizations, BP 138/80mmHg, HR 80, LDL 100mg/dL, HbA1c 6.9% Case examples 75 year old female with hypertension and recent onset edema, medications include Amlodipine 10mg QD for HTN Furosemide 20mg QD for edema KCl 10mEq QD for prevention of diuretic associated hypokalemia Recent status: BP 102/58mmHg, HR 99, c/o occasional dizziness, especially over the course of the morning 17

18 Additional data Amlodipine 10mg QD prescribed 2/19/14, Dr. X Furosemide 20mg QD prescribed 6/4/14, Dr. Y KCl 10mEq QD prescribed 6/4/14, Dr. Y Question Which of the following would best represent the type of medication related problem experienced by this patient? A. Polypharmacy B. use of a Beer s criteria drug C. Use of a STOPP criteria drug D. Prescribing cascade Case example comparing contrasting use of all tools A 79 year old male is transferred from a long term care living facility to the emergency department following a fall and a period of unresponsiveness. Past medical history includes a stroke 2 years ago associated with cognitive deficits and depression. Current medication list: terazosin 5mg daily and sertraline 100mg daily. About two hours after breakfast this morning, he was observed to rise from his wheelchair and attempt to ambulate unassisted down the hall. Staff members approached him to assist him back to his chair, but about 30 seconds after standing and before they could reach him, he was observed to attempt to grip the handrail, fall against the wall, and slide to the floor. 18

19 Upon initial assessment, he was unresponsive, and a few minutes later upon arousal he could not report any details of the event. His vitals after the fall were: BP 116/72mmHg, HR 106, T 97.7, RR 20. Routine vitals suggest a blood pressure range of 105/68mmHg to 148/82mmHg with HR in the 70 s and 80 s It is not clear from the record what time of day, which arm, or what method of assessment correspond to each value. Medical records review reveals that he has been a resident of the facility for six months. Prior to that time, his medication list included terazosin 5mg daily, sertraline 100mg daily, temazepam 15mg at bedtime, and aspirin 81mg daily. Functionally, he is able to feed himself (averaging % intake at mealtimes), and groom himself with supervision. He requires assistance with dressing, bathing and toileting, and is reliant upon adult briefs for incontinence. He is mobile at wheelchair level, requiring assistance with transfers and ambulation. Affect has been stable. Within the last two weeks temazepam was tapered and discontinued. No evidence of rebound insomnia documented in the record. Despite facility orders to obtain routine laboratory evaluation every six months, this was last performed eight months ago, revealing a CBC that is within normal parameters and the following serum chemistry values: Na 129, K 3.9, Cl 99, Co2 21, BUN 19, SCr 1.1, Gluc 105. His weight is 154lb, resulting in an estimated creatinine clearance of 54ml/min. What happened? The assessment was that this patient experienced a syncopal episode, possibly due to orthostatic hypotension. Alternative explanations include a transient ischemic attack, or dizziness associated with drug therapy combined with general functional decline. 19

20 Question Which of the following represent possible drug related contributors to this event? A. Side effects of terazosin or sertraline B. Recent discontinuation of temazepam C. Lack of preventative medication (aspirin) D. Any of the above are possible How would each tool have assessed this patient s regimen? Polypharmacy as indicator of medication appropriateness It is not likely this patient s regimen would have been flagged as potentially problematic by most definitions of polypharmacy How would each tool have assessed this patient s regimen? Applying explicit criteria to this drug regimen: Both the Beer s list and the STOPP criteria would identify the alpha adrenergic antagonist as being potentially inappropriate in a patient with a history of urinary incontinence, specifically stress incontinence. However, the type of urinary symptoms in the patient s history is not clear; it is possible that this medication was prescribed with the intent of improving urinary symptoms associated with bladder outflow obstruction. For that reason, it is possible that even if explicit criteria had flagged terazosin as potentially inappropriate, it may not have resulted in a change of therapy. 20

21 How would each tool have assessed this patient s regimen? STOPP criteria identifies the use of selective serotonin reuptake inhibitors in the presence of hyponatremia as inappropriate. However the parameters of this patient s case are outside the STOPP tool s specific criteria for this determination. START criteria would have identified the lack of aspirin therapy for stroke prevention How would each tool have assessed this patient s regimen? Applying implicit criteria: In attempting to perform the MAI, it is quickly evident that you cannot complete the score associated with the original tool due to missing data Indication is not clear for all drugs, therefore questions about efficacy and drug disease interactions are hard to score Note that indication for use and efficacy is unclear Simply using the structure of the MAI as a guide identifies several red flags that suggest medication inappropriateness How would each tool have assessed this patient s regimen? An application of the Naranjo causality assessment would not have been pertinent to prospectively identify any of these drugs as problematic Used retrospectively, it would assess terazosin as a probable cause of this adverse event and sertraline as a possible cause None of these tools are optimal for assessing the contribution of temazepam discontinuation ADWE scale may be applicable. Temazepam D/C would score as possible contributor but not probable 21

22 How would each tool have assessed this patient s regimen? Medication reconciliation Med rec performed at the time of facility admission would have flagged the absence of aspirin as an inconsistency with previous medication orders. Additional investigation would be required to determine whether discontinuation was intentional or simply an oversight Case conclusions A polypharmacy review would likely not identify this patient s medications as problematic Explicit tools would not have identified all of the issues Start / STOPP would have performed a bit better than Beers criteria The MAI would have identified important questions, but its execution would be hampered by lack of data Medication reconciliation would have identified the aspirin discrepancy but nothing else Performance could be enhanced with medical history or medication / indication data Next steps Regardless of the tool applied, additional data would be needed to implement drug therapy changes Clear diagnosis history Rationale for terazosin initiation was this for hypertension or for BPH? Clarification of incontinence type Confirmation of stroke history with absence of contraindications to, or adverse effects from, aspirin Updated laboratory monitoring 22

23 Operationalizing the tools Logistical realities in practice dictate implementation of appropriateness tools Data to apply the tools are derived from: Medical records documentation Medical/medication history Medication reconciliation practices Indicator or explicit criteria are logistically simpler Institutions that employ medication appropriateness tools satisfy some metrics of quality care Do they yield meaningful outcomes as far as morbidity, mortality, readmission related to medications? No single tool has demonstrated superiority Evaluations of the most recent update of the Beers list are still forthcoming A mixed approach of explicit and implicit criteria may be effective but must be validated All tools are best applied when supported by better / more accurate data Garbage in, garbage out principle Studies evaluating the efficacy of medication intervention programs show mixed results Muddy metrics Appropriateness of all drug therapy interventions based on explicit criteria are not always clear Ability to make concrete recommendations hampered by lack of data Better data to evaluate medication / indication match is the single most important change that would improve appropriateness assessment Medication and indication data MUST be accurate, complete, up to date, and readily evident to all members of the team 23

24 Lack of indication Indication is commonly not known May result in inappropriate continuation Assumptions of medication need May lead to addition of false diagnoses to medical record May result in inappropriate discontinuation Assumption of unnecessary medication May lead to adverse drug withdraw event and therapeutic failure What is needed? Software solutions for medical charting, order entry, and e scribing Training resources Enhanced standards for medication reconciliation Medication lists should include regimen details Where possible, this should include an approximation of usage for medications associated PRN instructions Indication for use and desired duration of use are the two most valuable pieces of information that are not currently a routine part of medication reconciliation but should be This way, even if explicit tools are used in a screening capacity to identify potentially inappropriate medications, their use can be combined with an evaluative process using implicit criteria 24