1、1,Updated Surveyor Guidance on Medications: F329,Steve Levenson, MD, CMD,2,OVERVIEW,3,Medications and Long-term Care,Medications are an integral part of long-term and subacute care Administered to try to achieve various outcomes, for example Curing acute illness Diagnosing disease or condition Arres
2、ting or slowing disease process Reducing or eliminating symptoms Preventing disease or symptoms,4,Prevalence of Medications,Study of 33,301 nursing facility residents in 2000 Average of 6.7 medications per individual Twenty-seven (27) percent of residents on nine or more medications.,5,Prevalence of
3、 Medications,Report (2001) Fifty-eight (58) percent of 693,000 residents who received antipsychotics either Lacked appropriate indications for use or Received doses exceeding maximum recommended dosage levels, including duplicative therapy,6,Medication Benefits and Risks,Medications can stabilize or
4、 improve outcome, quality of life, and function Any medication can have adverse consequences Potential to increase risk of adverse consequences Without adequate indications Excessive dose Excessive duration Without adequate monitoring,7,Taking Medications Seriously,8,Scope of the Problem,Medications
5、 are well-known public health problem Described in the medical, nursing, and pharmacology literature for many decades Discussed repeatedly in the mass media Relevant in every setting,9,Source: Parade Magazine, March 12, 2006,10,Why Focus on Problematic Drugs?,J Amer Bd of Family Practice, 95; 8:195-
6、205, Ackerman et al. “It is safe to assume that many of our nursing home patients are suffering from drug side effects, drug interactions, or both.” “Careful review and pruning of the medication list could be the single most important service the clinician can provide to his or her nursing home pati
7、ents” Ann Internal Medicine, (10/92), Vol. 43, No.4, Beers et al. Inappropriate medication prescribing common in NHs,11,ADRs Increase With Number of Medications,12,Warnings on Antibiotics,“Antibiotics may soon bear an official warning - that overusing them is wearing them out.” “Many common infectio
8、ns can no longer be treated by old standbys such as penicillin, and some even are becoming untreatable by the antibiotic of last resort, vancomycin.” “Infectious-disease experts have long warned that antibiotics are being overused.”Overuse of antibiotics makes remedies useless” - Baltimore Sun, Sept
9、. 20, 2000,13,Mistaking ADRs for Medical Illnesses,Elderly woman with frequent dizziness and falling On diuretic and ACE inhibitor for hypertension Despite lack of convincing evidence, cardiologist places pacemaker,14,Mistaking ADRs for Medical Illnesses,Patient has trouble with rehabilitation, feel
10、s lightheaded Lightheadedness persists despite stopping diuretic and ACE inhibitor After Sinemet dose cut from 25/250 t.i.d. to 10/100 t.i.d., lightheadedness stops and function improves to enable discharge,15,PDR: Sinemet,“Symptomatic postural hypotension has occurred when SINEMET is added to the t
11、reatment of a patient receiving antihypertensive drugs.”,16,Not Recognizing Risk,Elderly woman falls at home and fractures hip Treated on orthopedic service Medical consult obtained at beginning of stay; lytes OK, no further monitoring done Left on Aldactone throughout hospital stay, despite minimal
12、 evidence of serious history Arrives at SNF for rehab, but is delirious Repeat labs: sodium 111, K 2.0,17,Not Knowing or Believing Precautions,Elderly patient with atrial arrhythmia placed on amiodarone 200-400 mg. / day No monitoring of pulmonary, liver, thyroid, or eye function Overall condition d
13、eteriorates Signs of heart failure appear Patient given additional medications,18,Is This Something New?“,“The Doctors,” by Martin L. Gross, is a lengthy, well-researched critique which assails virtually every bastion of American medical education, research, practice and hospital careBaltimore Eveni
14、ng Sun,19,“The Doctors”,Mr. Gross takes dead aim on the high rate of illness caused by doctor-prescribed drugs. . . . As one authority told him, iatrogenic (doctor-caused) disease “can now take its place almost as an equal alongside bacteria as an important factor in the pathogenesis of human illnes
15、s.”,20,“The Doctors”,Study at famous American Hospital showed a high incidence of drug reactions in hospital patients “This has nothing specifically to do with the famous American Hospital,” he added. “The drug reaction rate is high all over the United States. Medicine in general has become indiscri
16、minate in its use of drugs,” he said. Dr. Cluffs survey 14% of 714 patients studied at the famous American Hospital got reactions from drugs administered to them,21,“The Doctors”,famous American Hospital Study 5% of famous American Hospital outpatient medical service in 4-week period had been made s
17、ick by drugs prescribed by private doctors Dr. Cluffs finding that 5 to 6 deaths in every 100 at famous American Hospital were caused by drug reactions “startled his colleagues” Dr. Cluff estimated that of 100,000 iatrogenic deaths per year nation-wide, half are caused by drugs According to another
18、survey made at Yale-New Haven Hospital, one in ten hospital deaths are caused by medical treatment and half of these by drugs, Mr. Gross said.,22,Is This Something New?,“The Doctors” a book review Baltimore Evening Sun OCTOBER 5, 1966,23,Unnecessary Drugs: F329,Overview and Interpretive Guidelines,2
19、4,INTENT: (F329) 42 CFR 483.25(l),Each residents entire drug/medication regimen is managed and monitored to achieve certain goals,25,INTENT: (F329) 42 CFR 483.25(l),An individual receives only medications clinically necessary to treat assessed condition(s) Appropriate doses for appropriate duration
20、Non-pharmacologic interventions considered and used instead of, or in addition to, medication when indicated For example, behavioral interventions for dementia-related behavioral symptoms,26,INTENT: (F329) 42 CFR 483.25(l),Medication or combination helps promote or maintain highest practicable physi
21、cal, functional, and psychosocial well-being Risks for adverse consequences or negative outcome(s) due to medication(s) are minimized,27,INTENT: (F329) 42 CFR 483.25(l),If individual experiences decline or newly emerging or worsening symptoms Change is recognized promptly Medication regimen evaluate
22、d as potential contributing or causative factor Changes made as appropriate,28,Factors Affecting Medication Utilization,Important considerations Underlying condition / current signs and symptoms Identification of root causes of symptoms Diagnosis alone may not warrant treatment with medication,29,Fa
23、ctors Affecting Medication Utilization,Multiple sources of medications Prescriptions from several practitioners Attending and on-call physicians Hospital physicians Specialists and consultants Nurse practitioners Hospice or dialysis programs Etc.,30,Warnings About Medication Risks,Food and Drug Admi
24、nistration (FDA) requirements Manufacturers labeling to include Warnings about serious adverse reactions and potential safety hazards What to do if they occur,31,Major Medication Risks,32,Access to References and Resources,Numerous references and resources related to medications and medication safet
25、y List or describe most significant risks, recommended doses, medication interactions, cautions, etc. Readily available to those who seek and use them,33,Access to References and Resources,Staff and practitioner access for safe prescribing Current medication references Pertinent clinical protocols a
26、nd guidelines Effective application of current standards of practice Consultant pharmacist as significant source of information,34,Applicability of F329,Surveyor guidelines focus generally on older adult resident But F329 requirements apply to individuals of all ages Special considerations may apply
27、 to gradual dose reduction and tapering medications in younger individuals,35,MEDICATION MANAGEMENT,36,Purpose of F329 Surveyor Guidance,Help surveyor determine whether the facility has a system for medication management that promotes key objectives regarding medications,37,Guidance To Surveyors,Gui
28、dance applies to all categories of medications including antipsychotic medications Surveyors review of medication use not intended to constitute practice of medicine However, surveyors are expected to investigate basis for decisions and interventions,38,Key Considerations,Indications for use Dosage
29、Duration Monitoring for effectiveness and adverse consequences Tapering / gradual dose reduction Preventing, identifying, and responding to adverse consequences,39,Medication Management System Objectives,Select medications based on assessing relative benefits and risks to individuals Evaluate underl
30、ying cause(s) of signs and symptoms, including those due to adverse medication consequences Use of medications in doses and for duration appropriate to individuals clinical conditions, age, and underlying causes of symptoms,40,Medication Management System Objectives,Use of non-pharmacologic interven
31、tions as indicated to Minimize need for medications Permit use of the lowest possible dose or allow medications to be discontinued, to extent possible Monitoring of medications for efficacy and side effects Especially, medications associated with risk of clinically significant adverse consequences,4
32、1,Medication Management Principles,Based in the care process including Recognition or identification of the problem/need Assessment of details Diagnosis/cause identification Management/treatment Monitoring including revising interventions, as warranted,42,Medication Management Principles,Attending p
33、hysician has key role in developing, monitoring, and modifying medication regimen In conjunction with Resident / patient and/or representatives Other professionals and direct care staff,43,Role of Other IDT Members,Identify, assess, address, monitor, and communicate signs and symptoms, needs, and ch
34、anges in condition Support individuals with limited ability to understand, communicate, or make decisions Consider resident / patient wishes, preferences, etc when selecting medication and non-pharmacological interventions,44,Indications,A pertinent patient evaluation helps Identify patient needs, c
35、omorbid conditions, and prognosis Determine causes and contributing factors affecting signs, symptoms and test results Select pertinent interventions Define clinical indications Provide baseline data to enable subsequent monitoring,45,Evaluation Addresses Important Questions,Do target symptoms and/o
36、r related causes warrant medication therapy? Are non-pharmacologic interventions relevant? Is a particular medication pertinent to managing symptoms or condition? Do intended or actual benefits justify risk(s) or adverse consequences?,46,Circumstances For Possible Medication Evaluation,Admission or
37、readmission Clinically significant change in condition/status New, persistent, or recurrent clinically significant symptom or problem Worsening of existing problem or condition,47,Circumstances For Possible Medication Evaluation,Otherwise unexplained decline in function or cognition Non-specific sym
38、ptom not otherwise attributable to underlying cause New medication order Renewal of orders Irregularity identified in consultant pharmacists monthly MRR,48,Monitoring,Key objectives for monitoring medications Track progress towards therapeutic goal(s) Detect emergence or presence of adverse conseque
39、nces,49,Adverse Consequences,Common enough to warrant serious attention and close monitoring Study (published in 2005) 338 (42%) of 815 adverse drug events judged preventable Common omissions Inadequate monitoring Lack of response or delayed response to signs or symptoms or laboratory evidence of me
40、dication toxicity,50,Adverse Consequences,Any medication can cause adverse consequences Some occur quickly or abruptly Others more insidious; develop over time May become evident Shortly after initiating medication Change in dose By tapering or discontinuing a medication,51,Follow-Up,Review Is medic
41、ation regimen promoting or maintaining highest practicable level of function? Are therapeutic goals being met? Is individual experiencing adverse consequences? Are current medications and doses still appropriate, or should they be reduced, changed, or discontinued?,52,Tapering / Gradual Dose Reducti
42、on (GDR),Possible indications for tapering any medication dose Individuals clinical condition has improved and/or declined Medication no longer beneficial or indicated Continued use of a medication may be considered excessive dose Example Discontinue cough, cold, and allergy medications after acute
43、upper respiratory symptoms resolved,53,Duration,Periodic re-evaluation of medication regimen To determine need for prolonged or indefinite use of a medication Many conditions require treatment for extended periods Others may resolve and no longer require medication therapy Examples: nausea and/or vo
44、miting, acute pain, psychiatric or behavioral symptoms, itching, cough and cold symptoms,54,What Can the Physician Do?,55,F329: Compliance Strategies,Understand the issues Recognize the risks Know what is expected Use medications carefully Perform adequately detailed assessments Base decisions on ev
45、idence Including results of careful assessments Justify long-term use,56,F329: Compliance Strategies,Monitor closely Effectiveness Adverse consequences Be on the lookout for adverse consequences Rule out adverse drug consequence when New symptoms occur Existing symptoms dont stabilize or improve,57,
46、F329: Compliance Strategies,Act promptly when adverse consequences suspected or identified Provide relevant patient-specific documentation to explain decisions,58,Ultimate Responsibility,Physicians have primary responsibility to Make appropriate decisions about medications Identify, anticipate, and
47、manage medication-related problems Based on input from others and own reviews,59,Minimizing Risk of Adverse Consequences,Considerations prior to prescribing Safety Tolerability Ease of dosing Potentially troublesome medication-medication interactions Often, but not always, can be anticipated or prev
48、ented Or, negative effects can be minimized,60,Avoiding Adverse Consequences: Strategies,Follow relevant clinical guidelines Recognize and take seriously warnings and recommendations for dosage, duration, and monitoring Always consider adverse consequences as a possible source of new, worsening, or
49、unrelieved symptoms and condition changes,61,Adverse Consequences: Evidence,Study of 18 community-based nursing homes 50 percent (276/546) of adverse consequences considered preventable 72 percent of fatal, life-threatening, or serious adverse consequences were preventableGurwitz JH, Field TS, Avorn
50、 J, et al Incidence and preventability of adverse drug events in nursing homes. American Journal of Medicine. 2000;109:87-94,62,Adverse Consequences: Evidence,Studied 2 academic-based NHs Identified frequent causes of preventable adverse consequences Inadequate monitoring / failure to act Errors in ordering Including wrong dose, wrong medication Medication-medication interactions Gurwitz JH, Field TS, Judge J, et al. The incidence of adverse drug events in two large academic long-term care facilities. American Journal of Medicine. 2005;118:251-258,
