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Minnesotas Call To Action Minnesotas Call To Action For Unnecessary Medications (F329) & Pharmacy Services (F425, 428, 431)

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Presentation on theme: "Minnesotas Call To Action Minnesotas Call To Action For Unnecessary Medications (F329) & Pharmacy Services (F425, 428, 431)"— Presentation transcript:

1 Minnesotas Call To Action Minnesotas Call To Action For Unnecessary Medications (F329) & Pharmacy Services (F425, 428, 431)

2 TJ/CMS Overview of New Guidance Not about medications, its about the resident. We have complex elderly residents with multiple medical disorders and multiple medications; medication-related issues are not uncommon. Do not manage medications; manage residents who take medications (holistic approach to medication management). Need a coordinated, systematic, facility-wide approach to the resident care process, not an individual discipline approach.

3 TJ/CMS Overview of New Guidance Use an interdisciplinary approach with individualized care to monitor and manage all medications. Therefore an increased responsibility of facility, prescribers, consultant pharmacist, and dispensing pharmacy regarding medication management. Try not to be overwhelmed; its good resident care. Remember, the regulations havent changed, the descriptions or interpretive guidelines have. Start learning about the guidance and begin implementing changes. Expect more changes, revisions in the future.

4 TJ/CMS Coordination & Communication Now is the time to begin talking to one another…share ideas for implementation, develop a plan for transitioning to the new guidelines, collaboratively write/review/update policies and procedures Considered keeping a notebook in the facility so that they can write down questions or issues as they arise, then can review with pharmacist, medical director, physicians, QA Committee, others.

5 TJ/CMS Coordination & Communication Examples of where communication is mentioned in new guidelines… F425: Develop mechanisms for communicating, addressing, and resolving issues related to pharmaceutical services F425: Interacting with the quality assessment and assurance committee to develop procedures and evaluate pharmaceutical services…

6 TJ/CMS Coordination & Communication Examples of where communication is mentioned in new guidelines… F329: It is important that the facility clearly identify who is responsible for prescribing and identifying the indications for use of medication(s), for providing and administering the medication(s), and for monitoring the resident for the effects and potential adverse consequence of the medication regimen; This is also important when care is delivered or ordered by diverse sources such as consultants, providers, or suppliers (e.g., hospice or dialysis programs) F425: Coordinate pharmaceutical services if and when multiple pharmaceutical service providers are utilized (e.g., pharmacy, infusion, hospice, prescription drug plans [PDP])

7 TJ/CMS F329 Whats Changed? Only the Guidance has changed. Increased information on indication, monitoring, adverse consequences for broader range of types of medications Modification of Gradual Dose Reduction Inclusion of tapering

8 TJ/CMS F425, 428, 431 Whats Changed? Only the Guidance has changed. Increased information on what is pharmaceutical services. Increased information about Medication Regimen Review.

9 TJ/CMS Development of the Guidance Pharmacy Services and Unnecessary Medications Involved 2 separate expert panels for both the pharmacy services tags and unnecessary medication tags Released for 1st public comment period - October st Comment period ended - January 2005 Expert panels reconvened - April 2005 Due to significant number of comments received during 1st comment period and subsequent revisions, a 2nd draft was released September 2005 Expert panels reconvened again - December 2005/January 2006 Final documents released - September 15, 2006 Effective date/implementation scheduled for DECEMBER 18, 2006

10 TJ/CMS Tags Combined Unnecessary Medications New Tag F329 = Old Tags F329, F330, F331 Unnecessary Drugs Pharmaceutical Services New Tag F425 = Old Tags F425, F426, and F427 (b) (1) Pharmaceutical Services, Procedures, Consultation New Tag F428 = Old Tags F428, F429, F430 Medication Regimen Review (DRR) New Tag F431 = Old Tags F427 (b) (2) and (3), F431, F432 Control, Labeling, and Storage

11 F329 Unnecessary Medications Interpretive Guidelines

12 TJ/CMS Medications and Long-Term Care Medications are an integral part of long-term and subacute care Can improve function and quality of life Can help attain various outcomes, for example Curing acute illness Diagnosing disease or condition Arresting or slowing disease process Reducing or eliminating symptoms Preventing disease or symptoms Medications are probably the single most important health care technology in preventing illness, disability, and deaths in the geriatric population (Avorn 1995)

13 TJ/CMS Scope of the Problem Medications are also a 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

14 TJ/CMS Source: Parade Magazine, March 12, 2006

15 TJ/CMS Drug-Related Problems (Categories) 1. A medical indication for the drug 2. Too little of the correct drug 3. Too much of the correct drug 4. Incorrect drug 5. Medical problem secondary to adverse drug reaction 6. Drug-drug, drug-food, drug-lab test interactions 7. Medical problem due to patient not receiving drug 8. Medical problem resulting from a drug for which there is no valid medical indication

16 TJ/CMS Not a New Concern J Amer Bd of Family Practice, 95; 8: , 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 patients Ann Internal Medicine, (10/92), Vol. 43, No.4, Beers et al. Inappropriate medication prescribing common in NHs

17 TJ/CMS Economic Impact of Diseases Affecting Americans Age 65 and Older If adverse reactions to medications were classified as a disease, it would rank as the 5 th leading cause of death in the U.S. CV Disease$171 Billion Cancer$104 Billion Alz. Disease$100 Billion DM$92 Billion Medication-Related Problems$66.2 Billion JAMA April 1998


19 TJ/CMS Overview of Drug-Related Problems in the Elderly 25% of patients over 80 experience ADRs; 10% of patients <60. A 75 y.o. is 7 times more likely to experience an ADR than a 25 y.o. Frequency of ADRs in >60 y.o. is 2-7 times greater than <60 y.o. More likely to require hospital admission 6 X that of general population

20 TJ/CMS Medication Adverse Consequence Adverse drug reaction -Side effect -Toxic effect -Hypersensitivity -Idiosyncratic -Adverse medication interaction Medication-Food interaction Medication-Disease interaction 50-80% of adverse consequences are potentially avoidable without reducing therapeutic effects of medications. (Predictable)

21 TJ/CMS Allergic/Adverse Drug Reactions Drug Brief description of reaction Date of occurrence DrugReaction (date) Aspiring.i. upset Amoxicillinhives, itch (8/94) Erythromycindiarrhea (9/89) Haldolstiff neck/jaw (3/92)

22 TJ/CMS Study in 2 academic-based nursing homes Most frequent causes for the preventable adverse consequences: Inadequate monitoring Failure to act on monitoring Errors in ordering Wrong dose Wrong medication Medication-medication interactions

23 TJ/CMS Drug-Related Problems Consequences Treatment Failure New medical problem Subsequent Events Physician revisit Further Rx Urgent care visit ER visit Hospital admit LTCF admit Death No further attention

24 TJ/CMS $80 billion/year spent on prescription drugs in U.S. $76.6 billion/year spent on drug-related problems. - $47 billion related to hospital admissions million hospital admissions - 17 million ER visits >200,000 deaths/year due to ADRs.

25 TJ/CMS For every $1.00 spent on drugs for nursing home patients, $1.33 is spent on treating the problems these drugs cause. ($4 billion/yr) Gurwitz, JH, et al. The incidence of adverse drug events in two large academic long term care facilities. AmJMed 2005:118: The statutory criteria for Medication Therapy Management Services (i.e., multiple chronic disease, multiple drugs, drug expenditures > $4,000/yr) will probably result in similar acuity levels for ambulatory patients. Kidder, Samuel W. DUR by Pharmacists-Lessons Learned for MTMS. The Consultant Pharmacist 12/2005

26 TJ/CMS Hx:81 yo female with mild HTN, OA, OP. Total Hip Replacement scheduled 7/23/04. Hx:81 yo female with mild HTN, OA, OP. Total Hip Replacement scheduled 7/23/04. 7/16/04:Weakness, ataxia, cognitive impairment. 6pm E.R. visit & 11pm hospital admit. (R/O CVA. Carotid ultrasound, CT head, MRI head, BP 184/110, mild Na+). Medications on admission: Lisinopril 5mg q.d.HCTZ 12.5mg q.d. Fosamax 70mg q. wkCalcium w Vit D b.i.d. ASA E.C. 325 q.d.Vioxx 25mg q.d. Alprazolam 0.25mg t.i.d.prnVicodin 1-2 q. 6 hr prn

27 TJ/CMS /17/04:12noon CNS Sx improved. All tests negative. Lisinopril increased to 10mg q.d. Atenolol 25mg q.d. added. Alprazolam, Vicodin, HCTZ held. BP 130/82

28 TJ/CMS /17/04:1:00pm T.J. call to vendor pharmacy to obtain Rx history. -Alprazolam 0.25mg x 30 1/18/04, 3/11/04, 4/27/04, 6/3/04, 6/24/04, 7/14/04 -Vioxx 25mg x 286/25/04 -Vicodin x 1007/14/04 1:30pm Physician arrives

29 TJ/CMS Etiology of Drug-Related Problems 1. 3 different prescribers 2. Lack of pharmacist intervention 3. Weakness, ataxia, impaired cognition Alprazolam, Vicodin 4. Elevated BP Antagonism of ACE Inhibitor (lisinopril) antihypertensive effect by Vioxx as well as possible Vioxx-induced HTN. 5. Hyponatremia Possibly Vioxx and HCTZ

30 TJ/CMS /18/04:10am Discharged after 40 hr hospitalization 1pm On dock at lake 2pm Pontoon ride Spends rest of day enjoying children and grandchildren. 7/23/04:Successful hip replacement surgery


32 TJ/CMS Medication Related Problem Expenses : -Telemetry $1,770/d x 2 days -ER Room $1, CT head $1,074 -MRI head $2,126 -Carotid Ultrasound $821 -Pelvis X-Ray $208 -EKG $177 -Labs/BMPs, CBC, UA, UC, TSH, B12, troponin, lytes, medications, PT/OT evaluation, etc.

33 TJ/CMS Hospitalization Bill for 40 hour admission $13,198.50

34 TJ/CMS F329 Intent Select medications based on assessing relative benefits and risks to individual Evaluate individuals signs and symptoms to identify underlying causes, including adverse consequences Select and use of medications in doses and for duration appropriate to individuals clinical conditions, age and underlying causes of symptoms Use of non-pharmacological interventions, when applicable, to minimize need for medications, permit use of lowest possible dose, or allow discontinuation of medications Monitor efficacy and clinically significant adverse consequences of medications

35 TJ/CMS Preserve Quality of Life

36 TJ/CMS Unnecessary Medications (1) General. Each residents drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used: (i) In excessive dose (including duplicate drug therapy); or (ii) For excessive duration; or (iii) Without adequate monitoring; or (iv) Without adequate indications for its use; or (v) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or (vi) Any combinations of the reasons above.

37 Unnecessary Medications (2) Antipsychotic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that (i)Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and (ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.

38 TJ/CMS Definitions Adverse consequence Adverse consequence - is an unpleasant symptom or event that is due to or associated with a medication, such as impairment or decline in an individuals mental or physical condition or functional or psychosocial status. It may include various types of adverse drug reactions and interactions (e.g., medication-medication, medication-food, and medication-disease). Behavioral interventions - Behavioral interventions - individualized non-pharmacological approaches (including direct care and activities) that are provided as part of a supportive physical and psychosocial environment and are directed toward preventing, relieving, and/or accommodating a residents distressed behavior.

39 TJ/CMS Definitions Clinically significant Clinically significant - refers to effects, results, or consequences that materially affect or are likely to affect an individuals mental, physical, or psychosocial well-being either positively by preventing, stabilizing, or improving a condition or reducing a risk, or negatively by exacerbating, causing, or contributing to a symptom, illness, or decline in status. Distressed behavior - is behavior that reflects individual discomfort or emotional strain. It may present as crying, apathetic or withdrawn behavior, or as verbal or physical actions such as: pacing, cursing, hitting, kicking, pushing, scratching, tearing things, or grabbing others.

40 TJ/CMS Definitions Indications for use Indications for use - is the identified, documented clinical rationale for administering a medication that is based upon an assessment of the residents condition and therapeutic goals and is consistent with manufacturers recommendations and/or clinical practice guidelines, clinical standards of practice, medication references, clinical studies or evidence-based review articles that are published in medical and/or pharmacy journals.

41 TJ/CMS Definitions Monitoring Monitoring - is the ongoing collection and analysis of information (such as observations and diagnostic test results) and comparison to baseline data in order to: Ascertain the individuals response to treatment and care, including progress or lack of progress toward a therapeutic goal; Detect any complications or adverse consequences of the condition or of the treatments; and Support decisions about modifying, discontinuing, or continuing any interventions. Psychopharmacologic medications Psychopharmacologic medications - any medication used for managing behavior, stabilizing mood, or treating psychiatric disorders.

42 TJ/CMS Non-pharmacological Interventions Increasing the amount of resident exercise, intake of liquids and dietary fiber in conjunction with an individualized bowel regimen to prevent or reduce constipation and the use of medications (e.g. laxatives and stool softeners). Identifying, addressing, and eliminating or reducing underlying causes of distressed behavior such as boredom and pain. Utilizing music-aroma-pet therapy, etc. Using sleep hygiene techniques and individualized sleep routines; assess exercise, naps, caffeine, fluids, environment. Accommodating the residents behavior and needs by supporting and encouraging activities reminiscent of lifelong work or activity patterns, such as providing early morning activity for a farmer used to awakening early.

43 TJ/CMS Overview Non-pharmacological approaches require assessing and understanding causes for need of medication ABCs: Antecedent…..Behavior….Consequence. Approaches involve reduction/elimination of impediments, triggers and causes Examples of Non-Pharmacological Interventions: Modification of environment Modification/elimination of psychological stressors Accommodation of previous lifelong activities or roles Modification of staff/resident interactions Behavioral Interventions

44 TJ/CMS Medication Management Resident Choice & Advance Directives Indications for Use Monitoring Dose Duration Tapering/ Gradual Dose Reduction Adverse Consequences

45 TJ/CMS Medication Management Is based in the Care Process. Attending physician plays a key leadership role in developing, monitoring, and modifying the medication regimen in conjunction with the Interdisciplinary Team, comprised of: The resident Their representatives Other professionals Direct care staff

46 TJ/CMS Promoting Care Process F329 notes that medication management is based in the care process Recognition or identification of the problem/need/risk Assessment (gathering details) Diagnosis/cause identification Management/treatment Monitoring Revising interventions, as warranted

47 TJ/CMS Strategies: Care Process Advise prudent disease management Must be in context Needs a sound biological basis Hard to isolate targeted organs Often invokes the law of unintended consequences

48 TJ/CMS The Cascade Effect Symptoms (including those related to medications often part of a cascade of problems Medication lethargy decreased oral intake fluid/electrolyte imbalance further lethargy weight loss skin breakdown Pneumonia confusion medication lethargy skin breakdown

49 TJ/CMS Medication Management Members of the interdisciplinary team participate in the care process by: identifying, addressing, advocating for, monitoring, and communicating the residents needs and changes in condition. Selecting medications and non-pharmacological interventions

50 TJ/CMS Challenges Nonpharmacologic interventions can be contrary to the instincts of some physicians, consultant pharmacists, and nurses Often require somewhat more time for staff to deliver, practitioners to identify Promoting a patient-centered approach The easy way out is often harder on the patient Medications should not constitute path of least resistance

51 TJ/CMS When treating the disease, treat the whole patient & consider therapeutic alternatives Elderly patient with CHF, DM, HTN Medications: Lasix, KCl, Lanoxin, Glucotrol, Calan SR Alternative: ACE Inhibitor (lisinopril) +/CHF, +/HTN, +HypoK, +/Diabetic nephropathy

52 TJ/CMS Clinical Strategies: Key Principles Respect for basic biology Good / Patient-Centered Coordinated care of individuals with [A+B+C+D+etc] Bad / Discipline (or Provider)-Centered [Care for patient with A] + [Care for patient with B] + [Care for patient with C] + [Care for patient with D] + [etc.]

53 TJ/CMS Discipline-Centered Care

54 TJ/CMS Resident/Patient-Centered Care

55 TJ/CMS Strategies: Multiple Prescribers Next day or Monday review of medications prescribed during nights and weekends Follow-up with attending physician of questionable orders, undefined symptoms, high-risk medications Emphasize attending physicians as being responsible for coordinating all medical orders, prescribing gatekeepers Clear identification of, and limits on, roles of consultants, providers, or suppliers (e.g., hospice, pain clinic, psychiatry, specialists, dialysis programs)

56 TJ/CMS Strategies: Medications and Related Risks Promote use of references about how to care for patients with various conditions that may require medications Books, monographs, articles, PDR, etc Pertinent clinical protocols and guidelines Effective application of current standards of practice Computer-based resources Provide FDA / manufacturer warnings

57 TJ/CMS Compliance Strategies Encourage relevant patient-specific documentation to explain decisions Not a good pharmacy consultation Please provide a diagnosis to justify the continued use of this medication. They have a diagnosis; you should start a medication. Clearly distinguish economic-based recommendations from clinical ones

58 TJ/CMS Strategies: Promote Pertinent Documentation What should be documented? How did we identify the symptom How did we decide that the symptom reflected a problem? How did we decide the problem or symptoms required a treatment? How did we identify a cause (or decide a cause could not be identified)?

59 TJ/CMS Documentation And Care Process How did we decide the cause could (or could not) be treated? How did we decide that the cause should (or should not) be treated? Why did we decide that the treatment needed to include a medication? Why did we decide that a high-risk medication was indicated? How did we decide that an existing high-risk medication could not be discontinued or tapered? How did we try to prevent an ADR? How did we show that we were monitoring for a potentially significant ADR?

60 TJ/CMS Regarding Medications, Good Intentions Alone Are Not Enough

61 TJ/CMS Where in the clinical record would you look to obtain information about a residents medication regimen?

62 TJ/CMS Location of Information Hospital discharge summaries & transfer notes Progress notes & interdisciplinary notes History & physical examinations Resident Assessment Instrument (RAI) Plan of care Lab reports Professional consults Medication orders Medical Regimen Review (MRR) reports Medication Administration Records (MAR)

63 TJ/CMS Six Medication Management Considerations I.Indications for use of medication II.Monitoring for efficacy & adverse consequences III.Dose IV.Duration V.Tapering/gradual dose reduction (GDR) VI.Prevention, identification & response to adverse consequences

64 TJ/CMS I.Indications for Use of Medication

65 TJ/CMS Indications for Use of Medication Indications require evaluation of information such as: Co-morbid conditions, signs, and symptoms Goals and preferences Allergies, potential interactions Past and current medications and interventions Recognition of need for end-of-life or palliative care Refusal of care and treatment Assessment instruments and diagnostic tools

66 TJ/CMS Indications for Use of Medication Analysis is used to: Rule out other causes of symptoms Identify whether signs/symptoms are significant/persistent to warrant medication Determine if the medication addresses symptom/condition Identify whether the benefits outweigh risks

67 TJ/CMS Unnecessary Meds General Diagnosis alone may not warrant treatment with medication PRN meds - important to evaluate and document: Indication(s) Specific circumstances for use Frequency of administration Orders from multiple prescribers can increase residents chances of receiving unnecessary meds Although the guidelines generally emphasize the older adult resident, adverse consequences can occur at any age; therefore, these requirements apply to residents of all ages

68 TJ/CMS Indications for Use of Medication What do these 5 circumstances have in common? A clinically significant change in condition/status A new or recurrent clinically significant symptom A worsening of an existing problem or condition An unexplained decline in function or cognition Psychiatric disorders or distressed behavior

69 TJ/CMS What information would you consider when evaluating indication for use?

70 TJ/CMS Information Mental, physical, psychosocial & functional status Goals & preferences of the resident/designated representative Allergies History of prior & current medications and non- pharmacological interventions Recognition of need for end-of-life or palliative care Refusal of care & treatment RAPS

71 TJ/CMS Case Scenario Ms. D. is an 80-year-old female admitted 6 months ago to the nursing home. Her current clinical record describes her as follows: With general symptoms of cardiovascular disease Suspected s/s ischemic MI Dementia, history of seizures Care plan for mood and behavior, bowel & bladder incontinence, and weight loss.

72 TJ/CMS Case Scenario During the most recent certification survey, the pharmacy MRR notes were reviewed and a request to clarify indications for use of all medications was recommended in the last two monthly MRRs.

73 TJ/CMS Case Scenario Labs K+ = 3.6 (on admission) TSH = 2.5 (on admission) Weight 110 lbs (on admission) 97 lbs (6 months later)

74 TJ/CMS Case Scenario Olanzapine (Zyprexa) 5mg at bedtime for behaviors (yelling, and refusing care) Lorazepam (Ativan) 2mg vial IM for seizure activity Lorazepam (Ativan) 0.5mg for anxiety manifested by restless movement Temazepam (Restoril) 7.5mg at bedtime as needed for sleep Phenytoin (Dilantin) 100mg at 8am, and 200mg at 5pm KCL elixir 20mEq at 8am Levothyroxine (Synthroid) 100mcg daily Rantidine (Zantac) 150mg daily for GI distress Donepezil (Aricept) 5mg daily Isosorbide Dinitrate 20mg one tablet three times daily for angina Megesterol acetate (Megace) 800mg daily to increase appetite Atenolol (Tenormin) 50mg daily ASA 25mg/dipyridamole 200mg)(Aggrenox) one cap daily

75 TJ/CMS Clinical Triggers Admission or readmission Clinically significant change in condition/status New, persistent or recurrent clinically significant symptom or problem Worsening of existing problem/condition Unexplained decline in function or cognition New medication order or renewal order Irregularity in pharmacists monthly medication regimen review Multiple prescribers



78 TJ/CMS [FAX] Concern: Loretta in ER last night for epistaxis. Still c/o dizziness and headache today. Now states behind eye throbbing. BP now 160/92. BP this am 192/90 (with meds given). Physician lisinopril to 20 mg BID yesterday. Has only Tylenol 650 mg per standing orders. Any changes?

79 TJ/CMS Response by Physician: T#3. i – ii po q 4 to 6° prn pain if not allergic. BP should improve if pain. Toprol XL 25 mg i po daily - start today if BP remains high.

80 TJ/CMS Response by Pharmacist: Did Dr. know Loretta already on atenolol for BP? Might want to that or DC it & Δ to Toprol. Already receiving in addition to Zestril 20 mg BID, Norvasc 10 mg qd, HCTZ 25 mg qd, Atenolol 50 mg qd. Do you want to change above orders?

81 TJ/CMS nd Repsonse by Physician: D/C Toprol. *Would be nice to see med sheets when asking the [question] Any changes? My memory cant keep track of everyones meds (How is BP today? Better? ?HA better with pain meds)

82 TJ/CMS [FAX] Regarding: Resident has anxiety, should we Paxil (currently 10 mg qd) or add Ativan? Also, how often should we draw CEA? Physician Response: No more CEAs Ativan 0.5 mg po q 6° prn 15 mg qd

83 TJ/CMS [FAX] Regarding: Resident has been having trouble sleeping & would really like a gentle sleeping pill. Tylenol PM? Physician Response: Tylenol PM 1 tablet at bedtime (650/25 mg)

84 TJ/CMS [FAX] For Your Information: Resident is receiving Ativan 0.5 mg tab po 30 mins. before bath prn. We are wondering if she could benefit from Zyprexa to help her with her behaviors. Physician Response: What behaviors?

85 TJ/CMS Discussion (last slide): Resident was already on Depakote 125 TID since 1/06, and it was increased 2/06 to 250 TID. This was never mentioned in fax. F/U fax to MD: Frequently combative & resistant with cares, refuses to change soiled clothes for days and does not like to bathe. She slaps out & yells. = Rx Zyprexa 1.25 qd (3/06)

86 TJ/CMS Indication Considerations include whether…. An appropriately detailed evaluation/assessment has occurred Other causes of symptoms have been ruled out Signs, symptoms are persistent or clinically significant enough to warrant medication use Non-pharmacological interventions were considered Particular medication is indicated to manage that symptom/condition

87 TJ/CMS Indication Considerations include whether…. Intended or actual benefit justifies potential risks Residents goals and preferences (inc. end-of-life needs) have been considered Resident has allergies to the medication or the potential for interactions Effectiveness and adverse consequences from previous and current therapy have been considered

88 TJ/CMS Indication Resident started on risperidone for being resistive to cares. Did facility rule out other causes? Is resistance harmful? Is this behavior persistent? Were other interventions considered, tried?

89 TJ/CMS Question Which of the following is NOT an appropriate indication for an antipsychotic? A.Delirium B.Depression with psychotic features C.Schizoaffective disorder D.Wandering

90 TJ/CMS Summary Indication for Use: Evaluation of resident helps to identify needs, comorbid conditions & prognosis to determine factors that are affecting signs, symptoms and test results Clinical triggers warranting evaluation

91 TJ/CMS II.Monitoring for Efficacy & Adverse Consequences

92 TJ/CMS Monitoring for Efficacy & Adverse Consequences Steps in Monitoring Identify information and how it will be obtained and reported Determine frequency Define method to communicate, analyze and act Re-evaluate and updating approaches

93 TJ/CMS Monitoring for Efficacy & Adverse Consequences Monitoring for Efficacy & Adverse Consequences Sources may help to define monitoring criteria: Manufacturers package inserts, black-box warnings Facility policies and procedures Pharmacists Clinical guidelines or standards of practice Medication references Published clinical studies or articles

94 TJ/CMS Monitoring for Efficacy & Adverse Consequences Monitoring for Efficacy & Adverse Consequences Review Psychopharmacological and Sedative/Hypnotic medications quarterly Documentation must include: Residents target symptoms and effect of medication Changes in residents function Medication-related side effects or adverse consequences

95 TJ/CMS Importance of Monitoring Tracks progress towards therapeutic goals Detects emergence or presence of any adverse consequences BENEFIT RISK

96 TJ/CMS Monitoring Parameters Residents condition Pharmacological properties of medication & its risks Individualized therapeutic goals Potential for clinically significant adverse consequences

97 TJ/CMS Monitoring What is the purpose of monitoring? To incorporate medication-related goals and monitoring parameters into the residents comprehensive care plan In some cases, can refer to facilitys established protocols or P+Ps To optimize med therapy (BENEFITS) while minimizing adverse consequences (RISKS) To establish parameters for evaluating the ongoing need for the medications To verify or differentiate the underlying diagnoses/causes of signs and symptoms

98 TJ/CMS Monitoring What are the steps or components of monitoring? Identify the essential information and how it will be obtained and reported Determine the frequency and duration of monitoring Define the methods for communicating, analyzing, and acting upon relevant information Re-evaluate and update monitoring approaches Using QUANTITATIVE and QUALITATIVE monitoring parameters facilitates consistent and objective collection of info by facility

99 TJ/CMS Examples of tools used for determining baseline status as well as for monitoring may include, but are not limited to: Physiological, Cognitive, & Functional Status: Vital signs, ECG, lab studies, blood sugars, HgbA1C Resident Assessment Instrument (RAI) Minimum Data Set (MDS) Pain scales Physical Self Maintenance Scale (PSMS) Functional Alzheimers Screening Test (FAST) scale Mini-Mental Status Exam (MMSE) Confusion Assessment Method (CAM) Instrumental Activities of Daily Living Scale (IADL) Abnormal Involuntary Movement Scale (AIMS)

100 TJ/CMS Examples of tools used for determining baseline status as well as for monitoring may include, but are not limited to: Examples of tools used for determining baseline status as well as for monitoring may include, but are not limited to: Mood/Affect: Geriatric Depression Scale (GDS) Cornell Depression in Dementia Scale Mania Rating Scale Behavior Behavioral Pathology in Alzheimers Disease Rating Scale (Behave AD) Cohen-Mansfield Agitation Inventory (CMAI) Neuro-psychiatric Inventory-Nursing Home Version (NPI-NH)

101 TJ/CMS Case Scenario Ms. A is a 78 yr old woman recently admitted to the facility within the month after sustaining a fall at home and fracturing her ankle. She has a history of hypertension, stroke 2 yrs ago and heart attack in her 60s. She is being seen in physical therapy for rehab. Blood Pressure and pulse are checked daily in the morning.

102 TJ/CMS Case Scenario Medications Aspirin 325mg daily for prevention Naproxen 500mg twice daily for pain Lisinopril 30mg daily for hypertension Alendronate 70mg weekly for Osteoporosis

103 TJ/CMS Summary Monitoring Efficacy & Adverse Consequences: Track progress towards therapeutic goals Detect adverse consequences Parameters – residents condition, pharmacological properties & risks, individualized therapeutic goals, clinically significant adverse consequences Monitoring Tools and Methods job aid

104 TJ/CMS III.Dose (Including Duplicate Therapy)

105 TJ/CMS Dose influenced by: Tables/Drug References provide general guidance on doses Resident parameters (renal, hepatic, weight) Current condition, signs and symptoms Co-morbid conditions Type of medication Therapeutic goals Clinical response Concurrent medications Possible adverse consequences Route of administration Inputs from interdisciplinary team

106 TJ/CMS Dose influenced by: Lab tests (i.e., serum medication concentrations) are only rough guide Significant adverse consequences can occur even with lab results are within therapeutic range Lab results alone warrant evaluation, but do not necessarily warrant dose adjustment Other test results Therefore, …………….…………………………………..

107 TJ/CMS The same dose of a medication given two different people may cure one and harm the other. (2-edged sword)

108 TJ/CMS Drugs Dont Have Doses, People Do!

109 TJ/CMS Duplicate Therapy Use of 2 or more medications from the same therapeutic class or the use of medications with similar effects from several classes Generally not indicated Clinical rationale (because of different mechanisms, synergism, standards of practice) may result in justification to reach therapeutic goals, but needs to be monitored Potentially can increase the risk of adverse consequences

110 TJ/CMS Duplicate Therapy Duplicate therapy examples… Acetaminophen-containing products Multiple laxatives Multiple benzodiazepines Anticholinergic effects Documentation is necessary to clarify rationale for, benefits of, and monitoring of duplicate therapy

111 TJ/CMS Dose/Duplicative Therapy Is there justification for low or high doses? Are there medications in the same class? If yes is there any justification? Must Document.

112 TJ/CMS Summary Dose: Influencing factors - clinical response, possible adverse consequences, diagnosis, signs & symptoms, current condition, age, coexisting medication regimen, lab & other test results, therapeutic goals, type of medication Route of administration Duplicate therapy generally NOT indicated Dosage Tables & Drug Interaction Table job aids

113 TJ/CMS IV.Duration

114 TJ/CMS Duration Looking at resident conditions are medications being used for the appropriate time frames? Is condition still present? Acute vs. Chronic

115 TJ/CMS Importance of Duration Many conditions require treatment for extended periods, while others may resolve and no longer require medication Excessive Duration may lead to Increased risk of adverse consequences Increased risk of medication interactions Antibiotic resistance Inadequate Duration of Treatment may also lead to treatment failure

116 TJ/CMS Duration Some meds needed for extended periods, others shorter-term Acute conditions Cough/Cold Nausea/Vomiting Acute Pain Psychiatric/Behavioral Symptoms If stop date according to facility P+P, discontinuation should occur - otherwise document clinical rationale Clinical rationale for continued use of a medication may have been demonstrated in clinical record, or staff/prescriber may present clinical rationale

117 TJ/CMS Summary Duration: Periodic re-evaluation necessary Clinical rationale for continued use may be demonstrated in clinical record Staff or prescriber may present pertinent clinical reasons

118 TJ/CMS V.Tapering of Medication Dose/Gradual Dose Reduction (GDR) for Antipsychotic Medications

119 TJ/CMS Tapering/GDR Goals of Tapering or Gradual Dose Reduction (GDR): Determine lowest effective dose Discontinue medication that is no longer needed or of benefit to the resident Minimize exposure to increased risk of adverse consequences

120 TJ/CMS Tapering/GDR Indicated when: Clinical condition improves or stabilizes Underlying causes of original target symptoms have resolved Non-pharmacological interventions have been effective in reducing symptoms

121 TJ/CMS Non-Pharmacologic Behavioral Intervention

122 TJ/CMS Factors to Consider Coexisting medication regimen Underlying causes of symptoms Individual risk factors Pharmacological characteristics

123 TJ/CMS Tapering/GDR: Real Impact New classes of medications added to those needing tapering Categories of GDR: Antipsychotics Categories of Tapering: Sedative Hypnotic, Other Psychopharmacologic medications.

124 TJ/CMS Behavior Monitoring So, which med classes mention behavior monitoring? According to Table 1… Antipsychotics Before initiating or increasing for enduring condition, target behaviors must be clearly and specifically identified and monitored objectively and qualitatively Anxiolytics When used for delirium, dementia, and other cognitive disorders with associated behaviors, behaviors to be quantitatively and objectively documented

125 TJ/CMS Pharmacologic Behavior Management Often over-rated, over-utilized, and lacking adequate documentation.

126 TJ/CMS GDR/Tapering for Antipsychotics Old: The length of time before an antipsychotic dose reduction is attempted should be consistent with the condition being treated Frequency of GDR: twice a year (for residents with organic mental syndrome) GDR is clinically contraindicated if two previous attempts within the last year led to a return of symptoms or return to the previous dose was necessary OR physician provides clinical rationale OR the patient has a specific DX and meets criteria listed in guidelines

127 TJ/CMS GDR/Tapering for Antipsychotics GDR and behavior monitoring now applies to antipsychotics no matter what the indication - behavioral symptoms related to dementia OR psychiatric disorder! No more exemption for psychiatric special conditions as mentioned in current guidelines

128 TJ/CMS GDR/Tapering for Antipsychotics New: Within 1st year after admission on antipsychotic or after initiation: GDR in 2 separate quarters, with at least one month between attempts After 1st year, GDR annually GDR is clinically contraindicated if:

129 TJ/CMS Antipsychotic indication & GDR Contraindications Behavioral symptoms related to dementia The residents target symptoms returned or worsened after the most recent attempt at a GDR within the facility; AND The physician has documented the clinical rationale for why any additional attempted dose reduction at that time would be likely to impair the residents function or increase distressed behavior.

130 TJ/CMS Antipsychotic indication & GDR Contraindications Other psychiatric disorders (e.g., schizophrenia, bipolar mania, depression with psychotic features) The continued use is in accordance with relevant current standards of practice and the physician has documented the clinical rationale for why any attempted dose reduction would be likely to impair the residents function or cause psychiatric instability by exacerbating an underlying psychiatric disorder; OR

131 TJ/CMS Antipsychotic indication & GDR Contraindications Other psychiatric disorders (e.g., schizophrenia, bipolar mania, depression with psychotic features) The residents target symptoms returned or worsened after the most recent attempt at a GDR within the facility and the physician has documented the clinical rationale for why any additional attempted dose reduction at that time would be likely to impair the residents function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder.

132 TJ/CMS Antipsychotics BW has been at the facility for the last 6 months. According to the physician order sheet (POS) the dose of the patients haloperidol was reduced approximately 3 months ago without any worsening of behavioral symptoms of dementia namely the hallucinations.

133 TJ/CMS Tapering for Sedatives/Hypnotics Old: Begin tapering after 10 days of continuous daily use Frequency: three times within 6 months Tapering is clinically contraindicated if three attempts within the last 6 months led to a decline

134 TJ/CMS Tapering for Sedatives/Hypnotics New: For as long as a resident remains on a sedative/hypnotic that is used ROUTINELY and beyond the manufacturers recommendations for duration of use, the facility should attempt to taper the medication quarterly unless clinically contraindicated. Sedatives/Hypnotics now include… New agents (non-benzodiazepine) Sedating antidepressants (e.g., trazodone) Sedating antihistamines (e.g, hydroxyzine)

135 TJ/CMS Sedatives/Hypnotics MH is an 82 yr WF who has been at the facility for the last 3 months. She is taking temazepam at bedtime.

136 TJ/CMS Tapering for Psychopharmacological Meds Old - ONLY APPLIES TO BENZODIAZEPINES: Begin taper after 4 months of continuous daily use Frequency: twice a year Tapering is clinically contraindicated if two previous attempts within the last year led to a decline No mention of tapering of other pharmaceutical classes mentioned in old guidelines

137 TJ/CMS Psychopharmacological Medications Any medication used for managing behaviors, stabilizing mood, or treating psychiatric disorders Important to understand the indication for use because many psychopharmacological medications may be used for multiple indications (examples…)

138 TJ/CMS Tapering for Psychopharmacological Meds New: Psychopharmacological meds now grouped together, so more than just benzodiazepines What classes might this include or impact? According to Table 1…. Anticonvulsants Antidepressants Anxiolytics - including buspirone, antidepressants

139 TJ/CMS Psychopharmacological Medications GF is an 84 yr old resident who has been at the facility for 2 years. Since being admitted to the facility, he has been on the same dose of sertraline for h/o depression.

140 TJ/CMS Tapering Clinically Contraindicated Hypnotics The continued use is in accordance with relevant current standards of practice and the physician has documented the clinical rationale for why any attempted dose reduction would be likely to impair the residents function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder; OR

141 TJ/CMS Tapering Clinically Contraindicated Hypnotics The residents target symptoms returned or worsened after the most recent attempt at tapering the dose within the facility and the physician has documented the clinical rationale for why any additional attempted dose reduction at that time would be likely to impair the residents function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder.

142 TJ/CMS Psychopharmacological Medications Tapering Other Psychopharmacologic Meds The facility should attempt to taper the medication during at least two separate quarters (with at least one month between the attempts), unless clinically contraindicated. After the first year, a tapering should be attempted annually, unless clinically contraindicated

143 TJ/CMS Tapering Clinically Contraindicated Psychopharmacological Medications The continued use is in accordance with relevant current standards of practice and the physician has documented the clinical rationale for why any attempted dose reduction would be likely to impair the residents function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder; OR

144 TJ/CMS Tapering Clinically Contraindicated Psychopharmacological Medications The residents target symptoms returned or worsened after the most recent attempt at tapering the dose within the facility and the physician has documented the clinical rationale for why any additional attempted dose reduction at that time would be likely to impair the residents function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder.

145 TJ/CMS Tapering and GDR When would the interdisciplinary team evaluate the residents response to medications and consider reduction or discontinuation of medications?

146 TJ/CMS Tapering/GDR Opportunities for evaluation of medication, in regards to duration/dose: Consultant Pharmacists MRR Physicians visit or signing of orders During quarterly MDS review What to evaluate: Residents target symptoms and the effect of the medication on symptoms (e.g., severity, frequency) Changes in residents function during previous quarter (e.g., MDS) Whether resident experienced any medication-related adverse consequences during previous quarter

147 TJ/CMS The Art of Tapering/GDR Gradual (When in doubt, go slow) Try not to reduce by >1/4 to 1/3 dose every 1-3 months, or longer (Hypnotics possible quicker) Less likely to precipitate withdrawal dyskinesia Less likely to induce withdrawal anxiety, insomnia, exacerbation of symptoms More likely to result in achieving minimal effective dose PRN dosing can be part of tapering Educate nursing staff re: PRN use

148 TJ/CMS Summary Tapering/GDR: Tapering applies to ALL medications Regulations require attempted GDR only for antipsychotic medications Factors – coexisting medication regimen, underlying causes of symptoms, individual risk factors, pharmacological characteristics

149 TJ/CMS VI.Prevention, Identification & Response to Adverse Consequences

150 TJ/CMS Adverse Consequences Increased Adverse Consequence Risk Advanced age Multiple co-morbid conditions Number of medications Certain pharmacologic classes

151 TJ/CMS ADRs Increase With Number of Medications

152 TJ/CMS Strategies: Adverse Consequences Promote system to anticipate, monitor for, recognize, act upon adverse consequences Unanticipated decline, falls, confusion, anorexia, dizziness, lethargy, incontinence, etc Medication regimen gets discussed for every change of condition, new symptom, worsening of symptoms despite treatment, etc

153 TJ/CMS Adverse Consequences Delirium Common medication-related adverse consequence Individuals who have dementia may be at greater risk for delirium Delirium is associated with higher morbidity and mortality

154 TJ/CMS Importance Adverse consequences related to medications are common! In a 2005 study, 42% of adverse drug events were judged preventable Most common omissions included: Inadequate monitoring Lack of/delayed response to signs, symptoms, or laboratory evidence of medication toxicity

155 TJ/CMS Adverse Consequences Another study of 18 nursing homes reported that: 51% (276/546) of the adverse consequences were considered preventable 72% (171/238) of those considered as fatal, life- threatening, or serious were preventable 34% (105/308) of significant events were considered preventable

156 TJ/CMS Question According to the investigative protocol guidance, which of the following signs or symptoms may be associated with medications: A. Dehydration B. Constipation C. Bruising D. All of the above

157 TJ/CMS Adverse Consequences Any medication can cause adverse consequences Considerations include… Following relevant clinical guidelines and/or manufacturers specifications for use, dose, duration, monitoring Defining appropriate indications for use Determining that the resident Has NKA to the medication Is not taking other medications, products, food that would be incompatible Has no condition, history, or sensitivities that would preclude use of that medication

158 TJ/CMS Role of Beers Criteria Beers Criteria is not listed and titled as such (like they are in current guidelines)- But, Beers criteria medications are incorporated into pieces of the document (e.g., TABLES 1+2) New Beers criteria, as of 2003: Fink DM, Cooper JW, Wade WE. Updating the beers criteria for potentially inappropriate medication use in older adults. Arch Intern Med 2003;163: Article in May 2004 edition of The Consultant Pharmacist

159 TJ/CMS Summary Prevention, Identification & Responses to Adverse Consequences: Statistics demonstrate need & importance Tables I & II job aids Drug Information Resources job aid

160 TJ/CMS Table I: Medication Issues of Particular Relevance Examples of categories of medications that: Have potential to cause clinically significant adverse consequences Have limited indications for use Require precautions in selection or use Require specific monitoring

161 TJ/CMS Table II: Medications with Significant Anticholinergic Properties Anticholinergic side effects are common Medications in many categories have anticholinergic properties Use of multiple medications with anticholinergic properties may be particularly problematic

162 TJ/CMS TABLE I: Medication Issues of Particular Relevance Alphabetically lists examples of some categories of and/or specific medications that have the potential to cause clinically significant adverse consequences, have limited indications for use, require specific monitoring. or warrant consideration of risks vs. benefits Medications mentioned are not meant to be absolutely contraindicated for every resident, but that the medication has the potential to be unnecessary While Table 1 is 36 pages long, it does not include all categories nor all medications within a category

163 TJ/CMS TABLE I: Medication Issues of Particular Relevance Current (old) guidelines include daily dose recommendations for psychotropic medications Previous drafts of revised guidance did NOT include dose examples But, final document includes Daily Dose Thresholds for: Antipsychotics Anxiolytics Sedatives/Hypnotics

164 TJ/CMS Analgesics AcetaminophenAvoid >4 Gm/day, LFTs. NSAIDsTrial APAP alternative; interactions with ASA, anticoagulants, anti- platelet agents; risks for GI bleed, renal insuff, CHF; CNS effects with some NSAIDs. OpioidsShorter-acting agent trial before long-acting; avoid meperidine; ADRs. PentazocineLimited efficacy; >ADRs. PropoxypheneRisks > Benefits.

165 TJ/CMS Antibiotics AllConfirmed/suspected infection. (e.g., not for asymptomatic bacteruria) Aminoglycosides, Renal Fn, serum levels IV Vancoto minimize ADRs. NitrofurantoinRenal insuff (CrCl<60); ADRs (pulmonary, neuropathy).

166 TJ/CMS Anticoagulants, Anticonvulsants, Antidepressants WarfarinINRs; interactions AnticonvulsantsDuration based on indication; possible serum levels; ADRs on liver, bone marrow, derm., CNS, falls. AntidepressantsIndication; 2 or >; duration; GDR/tapering; worsening Sx; interactions; ADRs (CNS, GI, falls, seizures, serotonin syndrome). MAOIs; TCAsBP-tyramine; antichol., etc.

167 TJ/CMS Antidiabetic medications All : Blood sugar monitoring, HbA1c. ?Long-term sliding scale insulin use Avandia : visual/macular monitoring Actos, Avandia : Edema/CHF Metformin : renal function; contrast dyes; CHF Sulfonylureas : SIADH Chlorpropamide, Glyburide : >t½ = >hypoglycemia

168 TJ/CMS y.o. female in nursing home with CHF, DM 5/25/05: Hospitalized with SOB, fatigue, edema. Chest x-ray shows significant CHF/cardiomegaly. Dx: CHF exacerbation, severe peripheral edema, renal insufficiency. Hx: 5/12/05 Glucotrol XL 10mg q.d. decreased to 5mg q.d. and Actos 30mg q.d. started. Tx: Increase Lasix. Discontinue Actos. Start Lantus.

169 TJ/CMS Important History Hospitalized 7/04 with discharge diagnosis of Actos-induced exacerbation of CHF.

170 TJ/CMS Antifungals (systemic imidazoles) Significant interactions with warfarin, phenytoin, theophylline, sulfonylureas; also rifampin, cimetidine. Liver impairment

171 TJ/CMS Antimanic medications Lithium Caution with renal impairment, CV disease, severe debilitation, dehydration, sodium depletion. Serum level monitoring. Interactions : thiazides, ACEIs, NSAIDs

172 TJ/CMS Antiparkinson medications Confusion, restlessness, delirium, dyskinesia, dizziness, hallucinations, agitation, nausea. Postural hypotension, falls. Adverse effect dilemma

173 TJ/CMS Antipsychotics Analysis of antipsychotic use by 693,000 Medicare nursing home residents 28.5% received excessive doses 32.2% lacked appropriate indications for use

174 TJ/CMS Antipsychotic medications Diagnoses Schizophrenia Schizo-affective disorder Delusional disorder Mood disorder (Bipolar, depression with psychosis, etc.) Schizophreniform disorder Psychosis NOS Atypical psychosis Brief psychotic disorder Dementing illness with associated behavioral symptoms Medical illness or delirium with manic or psychotic symptoms

175 TJ/CMS Antipsychotics: Additional criteria Symptoms are due to mania or psychosis; OR Behavioral symptoms present danger to self or others; OR Symptoms are significant enough that the resident experiences: Inconsolable or persistent distress Significant decline in function Substantial difficulty receiving needed care

176 TJ/CMS Antipsychotics: Inadequate indications Wandering Poor self-care Restlessness Impaired memory Mild anxiety Insomnia Unsociability Inattention or indifference to surroundings Fidgeting Nervousness Uncooperativeness Verbal expressions or behavior not due to conditions listed under appropriate indications and that do not represent a danger to the resident or others

177 TJ/CMS Antipsychotic Dose Thresholds in Dementing Illnesses Chlorpromazine75mg Fluphenazine 4mg Haloperidol 2mg Loxapine10mg Molindone10mg Perphenazine 8mg Thioridazine75mg Thiothixene 7mg Trifluoperazine 8mg Aripiprazole 10mg Clozapine 50mg Olanzapine 7.5mg Quetiapine150mg Risperidone 2mg

178 TJ/CMS Antipsychotics: Monitoring/Adverse Consequences Anticholinergic Akathisia NMS Arrhythmias; heart-related events Falls Lethargy/Sedation Pseudoparkinsonism Blood sugar elevation Increased lipids Orthostatic hypotension TIA/CVA in dementia Tardive dyskinesia

179 TJ/CMS Tardive Dyskinesia Risk factors Increased age Brain damage, CVAs, seizures, etc. Total cumulative antipsychotic dose Antipsychotic dosage Antipsychotic agent

180 TJ/CMS Anxiolytics Indications BZDPs, Buspirone, antidepressants Dosage Duration (Tapering/GDR) Adverse Consequences Diphenhydramine, hydroxyzine: Not appropriate Meprobamate: addictive, sedating, not indicated

181 TJ/CMS Anxiolytics: Dosage Thresholds Flurazepam 15mg Chlodiazepoxide 20mg Clorazepate 15mg Diazepam 5mg Cloazepam 1.5mg Quazepam 7.5mg Esazolam 0.5mg Alprazolam0.75mg Oxazepam 30mg Lorazepam 2mg

182 TJ/CMS Cardiovascular medications Antiarrhythmics: mental function, falls, appetite, behavior, heart function Amiodarone: limited indications, pulmonary toxicity, hepatic, thyroid, heart failure, interactions with digoxin & warfarin Disopyramide: decrease contractility, heart failure, anticholinergic Antihypertensives: dose modification, gradually taper some, dizziness, postural hypotension, fatigue, risk for falls

183 TJ/CMS Cardiovascular medications Alpha blockers: significant hypotension and syncope with initial doses (slow titration); prazocin more CNS effects ACEIs: monitor K+, cough, renal failure, interactions that increase K+, angioedema Beta blockers: bradycardia, dizziness, fatigue, bronchospasm, depression, acute heart failure decompensation, mask tachycardia of hypoglycemia, increased effects in hepatic dysfunction

184 TJ/CMS Cardiovascular medications Ca+Channel blockers: constipation, edema, avoid short-acting Methyldopa: risk > benefit, bradycardia, sedation, depression Digoxin: Dx only includes CHF, AF, PSVT, Atrial flutter Diuretics: fluid-electrolyte imbalance, hypotension, urinary incontinence, falls Nitrates: HA, dizziness, lightheadedness, faintness, orthostatic hypotension

185 TJ/CMS Cholesterol lowering medications Statins: LFT monitoring, muscle pain, myopathy, rhabdomyolysis to kidney failure Cholestyramine: absorption interactions with other co-administered medications, constipation, dyspepsia, nausea, vomiting, abdominal pain Fibrates: LFT and CBC monitoring Niacin: glucose and LFT monitoring, gallbladder disease, gout, flushing

186 TJ/CMS Cognitive enhancers Cholinesterase inhibitors: evaluate continued use in advanced stages, cardiac conduction, insomnia, dizziness, N/V/D, anorexia, weight loss, caution in asthma-COPD Memantine: evaluate continued use in advanced disease, restlessness, distress, dizziness, somnolence, hypertension, HA, hallucinations, increased confusion

187 TJ/CMS Case Scenario AD is a 77 yr old female who has been recently admitted to the facility after the family was unable to care for her at home. Per the family, she is having continual episodes of urinary incontinence and her memory is getting worse. PMH: Alzheimers disease for 2 years, new onset diarrhea over last 1 -2 months, osteoporosis

188 TJ/CMS Case Scenario Medications Donepezil 10mg in the evening Loperamide 2mg as needed for loose stools Calcium 500mg and Vit D 400 IU twice daily

189 TJ/CMS Cough-Cold-Allergy Medications Limited duration (<14 days), unless documentation otherwise Antihistamines: anticholinergic effects, prefer topical, lowest dose-shortest duration, sedation, confusion, cognitive impairment, distress, dry mouth, constipation, urinary retention, falls. Decongestants: dizziness, nervousness, insomnia, palpitations, urinary retention, HTN.

190 TJ/CMS Gastrointestinal medications Prochlorperazine, promethazine Caution in Parkinsons, narrow-angle glaucoma, BPH, seizure disorder. Sedation, dizziness, postural hypotension, NMS Anticholinergic effects Extrapyramidal symptoms and T.D. Arrhythmias Trimethobenzamide Relatively ineffective; EPSE, lethargy, sedation, confusion

191 TJ/CMS Gastrointestinal medications Metoclopramide Risk > benefit Restlessness, drowsiness, insomnia, depression, distress, anorexia, EPSE, seizures PPIs, H-2 Antagonists Indications based on clinical symptoms &/or endoscopy Trial alternate analgesics before use for NSAID gastropathy H-2s: dosed per renal function; confusion Cimetidine drug interactions PPIs: risk of Clostridium difficile colitis

192 TJ/CMS Glucocorticoids Document necessity for continued use Hyperglycemia, psychosis, edema, insomnia, HTN, osteoporosis, mood lability, depression

193 TJ/CMS Hematinics EPO Assess anemia etiology before use Monitor BP, serum Fe/ferritin, CBC Excess dose/duration Polycythemia, MI, stroke Iron Not indicated for anemia of chronic disease Justify use >2months; >q.d. Baseline serum Fe or ferritin, periodic CBC

194 TJ/CMS Laxatives Flatulence, bloating, abdominal pain Bulk formers & stool softeners Adequate fluids to avoid bowel obstruction

195 TJ/CMS Muscle relaxants Poorly tolerated in elderly due to anticholinergic side effects, sedation, weakness Avoid abrupt cessation because of possible seizures or hallucinations Usage exception: Periodic use (1 x q. 3 months) for short duration (<=7days)

196 TJ/CMS Orexigenics (appetite stimulants) Assess and manage underlying cause of anorexia/weight loss first Monitor efficacy at least monthly Megesterol: fluid retention, adrenal insufficiency Oxandrolone: sexual side effects, fluid retention Dronabinol: tachycardia, orthostatic hypotension, dizziness, dysphoria, impaired cognition, falls

197 TJ/CMS Osteoporosis medications Bisphosphonates Specific administration guideline adherence Esophageal or gastric erosion Potential GI symptoms with corticosteroids, ASA, NSAIDs

198 TJ/CMS Platelet inhibitors ASA, Dipyridamole, Clopidogrel Thrombocytopenia, bleeding HA, dizziness, vomiting Caution with NSAIDs, warfarin Ticlodipine Risk > benefit (neutropenia) N, V, D

199 TJ/CMS Respiratory medications Theophylline Drug interaction potential Monitor serum levels, toxicity Inhalant medications Anticholinergics: dry mouth Beta agonists: restlessness, tachycardia, anxiety Steroids: throat irritation and candidiasis

200 TJ/CMS Sedatives/Hypnotics Rule out underlying causes of insomnia Environment Inadequate physical activity Facility routine issues Caffeine, stimulating mediations Pain, discomfort Co-morbid conditions (psychiatric, medical) Caution in sleep apnea Tapering/Gradual Dose Reduction guidelines Barbiturates: Avoid (risks > benefits)

201 TJ/CMS Daily Dose Thresholds for Sedative/Hypnotics Chloral hydrate 500mg Diphenhydramine 25mg Estazolam0.5mg Eszopiclone 1mg Flurazepam 15mg Hydroxyzine 50mg Lorazepam 1mg Oxazepam 15mg Quazepam7.5mg Ramelteon 8mg Temazepam 15mg Triazolam 0.125mg Zaleplon 5mg Zolpidem IR 5mg Zolpidem CR 6.25mg

202 TJ/CMS Thyroid medications Potential drug interactions affecting dosage Initiate at low dose, increase gradually Assess thyroid function studies periodically

203 TJ/CMS Urinary incontinence medications Assess underlying cause and identify type of incontinence: select medications accordingly Assess urinary symptoms periodically Monitor side effects

204 TJ/CMS Table II: Medications with Significant Anticholinergic Properties Anticholinergic side effects are common Medications in many categories have anticholinergic properties Use of multiple medications with anticholinergic properties may be particularly problematic

205 TJ/CMS Anticholinergic Side Effects Peripheral Blurred vision Dry mouth Constipation Urinary retention Central Labile mood Restlessness Wandering Ataxia Confusion Disorientation Agitation Psychosis Insomnia Delusions Decreased attention Span Memory impairment

206 TJ/CMS Table II: Anticholinergic Meds Examples of anticholinergic effects: Slowed digestive motility Constipation Decreased sweating Dry mouth, skin Elevated BP or HR Visual impairment Delirium Mental status changes (cognitive decline, restless, etc.) Urinary retention or difficulty Drowsiness, lethargy, weakness Dizziness

207 TJ/CMS Table II: Anticholinergic Meds Examples of medications with anticholinergic properties Antihistamines (H-1 blockers) Antidepressants (TCAs, paroxetine) Antivertigo (meclizine, scopolamine) Cardiovascular medications (furosemide, digoxin, nifedipine, disopyramide) GI meds Antidiarrheals (diphenoxylate/atropine) Antispasmodics (dicyclomine, hyoscyamine, etc.) Anti-ulcer agents (cimetidine, ranitidine)

208 TJ/CMS Table II: Anticholinergic Meds Examples of medications with anticholinergic properties Antiparkinson (amantadine, benztropine, biperiden, trihexyphenidyl) Muscle Relaxants (cyclobenzaprine, dantrolene, orphenadrine) Antipsychotic (chlorpromazine, clozapine, olanzapine, thioridazine) Phenothiazine (prochlorperazine, promethazine) Urinary Incontinence (oxybutynin, probanthaline, solifenacin, tolterodine, trospium)

209 TJ/CMS y.o. F. nursing home resident Meds: Furosemide 20mg b.i.d.Reglan 10mg b.i.d. Calcium 500mg t.i.d.Senna-S b.i.d. Risperdal 0.5mg b.i.d.Metamucil 1 tsp b.i.d. Hydroxyzine 25mg p.r.n.MOM 15 ml q.d. Cogentin 1mg b.i.d.Naproxen 375mg b.i.d. Medical Problems: DementiaConstipation DermatitisOsteoporosis EdemaParkinsonism Reflux esophagitisDJD

210 TJ/CMS Summary Six medication management considerations Indication for Use Monitoring Efficacy & Adverse Consequences Dose Duration Tapering/GDR Prevention, Identification & Responses to Adverse Consequences

211 TJ/CMS F425,428, 431-Whats Changed? Only the Guidance has changed. Increased information on what is pharmaceutical services. Increased information about MRR.

212 F428 Medication Regimen Review Interpretive Guidelines

213 TJ/CMS Intent The facility maintains residents highest practical level of functioning and prevents or minimizes adverse consequences related to medication therapy to the extent possible, by providing: Licensed pharmacists review of each residents medication regimen at least monthly - More frequent based on resident condition & risks or adverse consequences related to current medications Identification and reporting of irregularities Action taken in response to irregularities

214 TJ/CMS Overview Factors increasing the risk of medication related issues Multiple medications are often required to address conditions, leading to complex medication regimens Transitions, such as a move from hospital to nursing home – Medications may be added, discontinued or changed Adverse consequences can mimic symptoms of chronic conditions (aging process, new conditions)

215 TJ/CMS Common Manifestations of Adverse Drug Reactions in the Elderly That May Be Incorrectly Interpreted as Signs of Aging Confusion Depression Lack of appetite Weakness Lethargy Ataxia Forgetfulness Tremor Constipation Dizziness Diarrhea Urinary retention

216 TJ/CMS Disorders Precipitated or Exacerbated by Drugs Asthma:Beta Blockers (systemic, ocular) CHF:NSAIDs, glitazones Depression:Propranolol, Methyldopa, Clonidine Dizziness, BP:Numerous Essential Tremor:Beta Agonists, Lithium Edema:NSAIDs, glitazones, gabapentin, … Gout:Loop & Thiazide Diuretics Hypertension:NSAIDs, venlafaxine OBS:Anticholinergics, Benzodiazepines, … Parkinsonism:Antipsychotics, Asendin, Reglan PUD:NSAIDs Urinary Retention:Anticholinergics

217 TJ/CMS Cheney Hospitalized 1/9/2006, 06:37 AM Vice President Dick Cheney, 64, was taken to George Washington Hospital at 3 a.m. Monday experiencing shortness of breath, spokesman Steve Schmidt said. Doctors found his EKG unchanged and determined he was retaining fluid because of anti-inflammatory medication he was taking for a foot problem, Schmidt said without giving the name of the drug. Cheney, who has a history of heart problems and has a pacemaker in his chest, was placed on a diuretic. Schmidt said the Vice President was expected to be released from the hospital later Monday. A foot ailment forced the Cheney to use a cane Friday.

218 TJ/CMS Overview (continued) Reviews to help identify issues: Physician reviews orders and total program of care on admission and prescriber reviews at each visit Nurse reviews medications when sending orders to pharmacy and/or prior to administering medications Interdisciplinary team reviews as part of the comprehensive assessment for the RAI and/or care plan Pharmacist reviews the prescriptions prior to dispensing Pharmacist performs medication regimen review at least monthly

219 TJ/CMS Sources of Information May include, but are not limited to: MARs Prescribers orders Progress, nursing, consultants notes, H&P, discharge summaries RAI/MDS Lab reports Forms/reports reflecting behavioral monitoring and/or changes in condition QM/QI reports Attending physician, facility staff Interviewing, assessing, and/or observing the resident Ask yourself, how many of these do I use and should I be using more sources or different types of sources than I am now?

220 TJ/CMS MRR Considerations MRR considers factors, such as: Has physician/staff documented objective findings, diagnoses, symptoms to support indication? Has physician/staff identified and acted upon, or should they be notified about, residents allergies, potential interactions/averse consequences? Is dose, frequency, route, duration consistent with residents condition, manufacturers recommendations, and applicable standards of practice?

221 TJ/CMS MRR Considerations Has physician/staff documented progress towards or maintenance of the goal(s) for medications therapy? Has physician/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?

222 TJ/CMS MRR Considerations Has physician/staff noted and acted upon possible medication-related causes of recent or persistent changes in the residents condition?………………… ……think Geriatric Syndromes Anorexia and/or unplanned weight loss, or weight gain Behavioral changes, unusual behavior patterns Bowel function changes Confusion, cognitive decline, worsening of dementia Dehydration, fluid/electrolyte imbalance Depression, mood disturbance

223 TJ/CMS MRR Considerations Dysphagia, swallowing difficulty Excessive sedation, insomnia, or sleep disturbance Falls, dizziness, impaired coordination GI bleeding Headaches, muscle pain, generalized aching/pain Rash, pruritis Seizure activity Spontaneous or unexplained bleeding, bruising Unexplained decline in functional status Urinary retention or incontinence

224 TJ/CMS Location and Notification of MRR Findings The Pharmacist must Document identification of irregularity Report irregularity to attending physician or director of nursing Timeliness of notification depends on severity If no irregularities found, pharmacist signs statement indicating such

225 TJ/CMS Response to Irregularities Identified in the MRR Physician is not required to order recommended treatments unless he/she determines they are medically valid/indicated If recommendation requires physician intervention, then: Physician accepts and acts upon suggestion OR Physician rejects and provides explanation for disagreeing

226 TJ/CMS Response to Findings Physician either: Accepts recommendation and acts, OR Rejects 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

227 TJ/CMS 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, OR When attending and Medical Director are same, follow established facility procedure to resolve the situation No specific timeframe provided for when a report that is not acted upon officially becomes delinquent or not acted upon

228 TJ/CMS 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 its 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.

229 TJ/CMS F428 - MRR Definition of Medication Regimen Review: Thorough evaluation of the medication regimen of a resident, with the goal of promoting positive outcomes and minimizing adverse consequences associated with medications; the review includes preventing, identifying, reporting, and resolving medication-related problems (MRPs), medication errors, or other irregularities and collaborating with others members of the interdisciplinary team. So, what are these things were preventing, identifying, reporting, and resolving…how are MRPs, med errors, and irregularities defined?

230 TJ/CMS Medication-Related Problems 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 use Use of a medication without identifiable evidence that safer alternatives or more clinically appropriate medications have been considered

231 TJ/CMS Medication-Related Problems (cont.) Use 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 duration Presence of an adverse consequence associated with medication(s)

232 TJ/CMS Medication-Related Problems (cont.) Use of a medication without adequate monitoring - inadequate monitoring of response to med, or - inadequate response to findings/results Presence of or risk for medication errors Presence of a clinical condition that might warrant initiation of medication Medication interaction - TOP 10 DIs in LTC

233 TJ/CMS Common Medication Interactions in LTC Warfarin - NSAIDs Warfarin - Sulfonamides Warfarin - Macrolides Warfarin - Quinolones Warfarin - Phenytoin ACEI - Potassium suppl. ACEI - Spironolactone Digoxin - Amiodarone Digoxin – Verapamil Theophylline - Quinolones

234 TJ/CMS Medication Errors A medication error isnt 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. (Source:

235 TJ/CMS 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.

236 TJ/CMS F428 - MRR Given those definitions, it is important to note that the 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…

237 TJ/CMS Frequency of Review Monthly or more frequently, depending on: the residents condition, and the risks for adverse consequences related to current medications This sounds alarming, but it is virtually the same as current survey guidelines Remember, there was additional guidance related to this in F425

238 TJ/CMS 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 resident BUT new technology (electronic health records) may permit the pharmacist to conduct some components of the review outside of the facility

239 TJ/CMS Notification of Findings Timeliness of notification depends on potential for or presence of serious adverse consequences Examples include: - Bleeding resident on anticoagulants - Possible allergic reactions to antibiotic Collaborate with facility to identify the most effective means of notification/documentation Notification/documentation may be done electronically

240 TJ/CMS Location of Findings Pharmacists findings are part of clinical record If not maintained within active clinical record, it must still be maintained within facility and readily available Find balance between: Encouraging/facilitating other healthcare professionals to utilize Allowing facilities flexibility in determining a consistent location that suits their needs

241 TJ/CMS Considerations for Medication Regimen Review (MRR) When should I implement the new gradual dose reduction/tapering guidelines? Probably not wise to initiate dose reduction attempts on every psychopharmacological medication for every resident right away, just to comply with guidelines Might be more prudent, on an individual basis, to evaluate past gradual dose reduction/tapering attempts when considering future attempts…dont necessarily want the burden of managing dose reductions on a multitude of residents at one time

242 TJ/CMS Considerations for Medication Regimen Review (MRR) Chances are… dispensing pharmacists are most likely already providing proactive MRR, but it may not be identified or labeled as such F425: Providing pharmaceutical consultation is an ongoing, interactive process with prospective, concurrent, and retrospective components. To accomplish some of these consultative responsibilities, pharmacists can use various methods and resources, such as technology, additional personnel (e.g., dispensing pharmacists, pharmacy technicians), and related policies and procedures F428: Transitions in care such as a move from home or hospital to the nursing home, or vice versa, increases the risk of medication-related issues. It is important, therefore, to review the medications. Currently, safeguards to help identify medication issues include… The pharmacist reviewing the prescriptions prior to dispensing

243 F425 Pharmaceutical Services Interpretive Guidelines

244 TJ/CMS Definitions Pharmaceutical Services The process of receiving and interpreting prescribers orders; acquiring, receiving, storing, controlling, reconciling, compounding (e.g., intravenous antibiotics), dispensing, packaging, labeling, distributing, administering, monitoring responses to, using and/or disposing of all medications, biologicals, chemicals; The provision of medication-related information to health care professionals and residents; The process of identifying, evaluating and addressing medication-related issues including the prevention and reporting of medication errors; and The provision, monitoring and/or the use of medication-related devices.

245 TJ/CMS Intent Facility provides pharmaceutical services to meet the needs to residents Medications and biologicals Services of licensed pharmacist Pharmaceutical services are coordinated within the facility Procedures developed and implementation evaluated Pharmaceutical concerns and issues affecting residents and care are identified and evaluated Only persons authorized under state requirements administer medications

246 TJ/CMS Overview Provision of Medications Timeliness/Availability to meet needs of each resident Services of a Pharmacist The pharmacist is responsible for helping the facility obtain and maintain timely and appropriate pharmaceutical services that support residents healthcare needs, that are consistent with current standards of practice, and that meet state and federal requirements. Pharmaceutical Services Procedures Acquiring- Administering Receiving- Disposal Dispensing- Labeling/Storage, incl. Authorized personnel controlled substances

247 TJ/CMS Provision of Medications Factors that may help determine timeliness and guide procedures for acquisition include: Availability of meds to enable continuity of care for anticipated admission or transfer Condition of resident (e.g., severity/instability of condition, current S+S, potential impact of a delay) Category of medication (e.g., antibiotic, pain) Availability of medications in emergency supply Ordered start time

248 TJ/CMS Pharmacist Services Consultant pharmacists responsibilities, in collaboration with the facility and medical director, may include: - Develop, implement, evaluate, and revise (as necessary) procedures relating to pharmaceutical services -Coordinate pharmaceutical services if and when multiple service providers are utilized, for example: Multiple pharmacies Infusion provider Hospice Prescription Drug Plan (PDP)

249 TJ/CMS Pharmacist Services - IV therapy procedures -Determine contents & monitor use of E-Kits -Develop mechanisms for communicating, addressing, resolving issues related to pharmacy services -Strive to assure medications requested, received and administered in timely manner -Provide medication administration & medication error review and feedback -Participate on interdisciplinary team to address and resolve medication-related needs or problems

250 TJ/CMS Pharmacist Services -Establish procedures for Monthly Medication Regimen Review (MRR) (more on MRR in F428) Conducting monthly MRR for each resident Addressing expected time frames for conducting the review and reporting findings Addressing the irregularities Documenting and reporting results of the MMR Addressing MRRs for residents: anticipated to stay less than 30 days who experience an acute change in condition as identified by facility staff

251 TJ/CMS Pharmacist Services NOTE (in document): Facility procedures should address… how and when the need for a consultation will be communicated, how the medication review will be handled in the pharmacist is off-site, how the results or report of their findings will be communicated to the physician expectations for the physicians response and follow-up, and how and where this information will be documented.

252 TJ/CMS Pharmacist Services -Procedures/guidance regarding when to contact prescriber about medication issue &/or adverse effects, incl. info to gather before contact -Process for receiving, transcribing, and recapitulating med orders -Medication delivery system, packaging -Automated dispensing machines/delivery devices/cabinets -Medication references/resources -Facility educational/informational needs about medications

253 TJ/CMS Pharmaceutical Services Acquisition Receiving & Dispensing Administering Disposition Labeling Storage Controlled Drugs

254 TJ/CMS Labeling Labeling of meds prepared by facility staff (e.g., IVs) Requirements for non-pharmacy labels (e.g., OTC) Label changes due to change in order/directions Labeling of multi-dose vials (e.g., expiration dates)

255 TJ/CMS Controlled Substances Controlled Meds -Location, security and authorized access of Class II vs. III-V, including refrigerated CSs -Records of receipt and disposition for all controlled meds -Periodic reconciliation (e.g., frequency, method, by whom, documentation)

256 TJ/CMS F425 - Pharmaceutical Services This impacts dispensing pharmacies too -Emergency supply (E-Kits) and 24/7 availability - ensuring timeliness -Procedures for clarifying orders -Procedures for contacting prescriber -Procedures when medication is not available or delivery is delayed -Procedures for transporting meds between pharmacy and facility -Defining schedules for administering medications -Reporting of medication errors

257 TJ/CMS F425 - Pharmaceutical Services F425: Providing pharmaceutical consultation is an ongoing, interactive process with prospective, concurrent, and retrospective components. To accomplish some of these consultative responsibilities, pharmacists can use various methods and resources, such as technology, additional personnel (e.g., dispensing pharmacists, pharmacy technicians), and related policies and procedures

258 F431 Storage, Labeling, Controlled Medications Interpretive Guidelines

259 TJ/CMS Intent The facility, in coordination with the pharmacist, provides: Safe and secure storage and handling of all medication Accurate labeling to facilitate safe administration A system of records enabling reconciliation and accounting of controlled medications Identification of loss or diversion of controlled medications minimizing the time between actual loss and the detection of the extent of loss

260 TJ/CMS Labeling New Key Points As mentioned in F425, facility ensures labeling in response to order changes is accurate and consistent with state requirements (I.e., nurse cannot re-label or alter label) For meds designed for multiple administrations - Multi-Dose (e.g., inhalers, eye drops, etc), label is affixed in manner to promote administration to resident for whom it was prescribed In other words, if there isnt space for an entire label, still better have - at least - residents name on actual product container

261 TJ/CMS Labeling New Key Points For compounded IV preparations, label contains: Name and volume of solution Residents name Infusion rate Name and quantity of each additive Date of preparation Initials of compounder Date and time of administration Initials of person administering medication if different than compounder Ancillary precautions, as applicable Date after which mixture must not be used (i.e., expiration date)

262 TJ/CMS Labeling New Key Points For OTCs in bulk containers (in states that permit), label contains: Original manufacturers OR pharmacy-applied label indicating: Medication name Strength Quantity Accessory instructions Lot number Expiration date, when applicable If resident-specific supply of OTC, label contains above plus residents name

263 TJ/CMS Access and Storage New Key Points Access can be controlled by keys, security codes or cards, or other technology (e.g., fingerprints) Med pass… During a med pass, medications must be under the direct observation (vs. control ) of the person administering the medications or locked in the med storage area/cart Self-administration… Important that the facility have procedures for the control and safe storage of medications for those residents who can self-administer

264 TJ/CMS Storage, Labeling, Controlled Meds The facility must employ or obtain the services of a licensed pharmacist who: Establishes a system of records of receipt and disposition of all controlled medications (Class II-V) in sufficient detail to enable an accurate reconciliation. Determines that medication records are in order and that an account of all controlled medications is maintained and periodically reconciled.

265 TJ/CMS Controlled Medications Old vs. New Old: A record of receipt and disposition of controlled drugs does not need to be proof of use sheets; The facility can use existing documentation such as the Medication Administration Record (MAR) to accomplish this record

266 TJ/CMS Controlled Medications Old vs. New New : Record of RECEIPT of ALL controlled medications with sufficient to allow reconciliation, specifying: Name and strength of medication Quantity Date received Residents name (unless using automated dispensing machine, etc) Records of USAGE and DISPOSITION (destruction, waste, return, other disposal) of ALL controlled medications with sufficient detail to allow reconciliation, e.g., MAR Proof-of-use sheets Declining inventory sheets Emergency Kits…. Dont forget about controlled medications located in the emergency supply

267 TJ/CMS Controlled Medications Old vs. New Old: Periodic reconciliations should be monthly New: Periodic reconciliation of receipt, disposition, and inventory for ALL controlled medications (monthly or more frequently) Consultant Pharmacist is not required to perform reconciliation, but rather to evaluate and determine that the facility maintains an account of all controlled medications and completes reconciliation

268 TJ/CMS Controlled Medications Old vs. New Old: If they reveal shortages: Pharmacist and the director of nursing may need to initiate more frequent reconciliations Facility may have to utilize proof of use sheets on all controlled drugs for all shifts When the source of shortage is located and remedied, the facility may go back to periodic reconciliation by the pharmacist New: If discrepancies in records are identified or loss has occurred: Consultant Pharmacist and facility develop and implement recommendations for resolution Review and revise monitoring procedures, as necessary (e.g., increasing the frequency of reconciliation)

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