Presentation on theme: "Minnesota’s Call To Action"— Presentation transcript:
1Minnesota’s Call To Action For Unnecessary Medications (F329)&Pharmacy Services (F425, 428, 431)Message:These interpretive guidelines provide CMS’ authoritative interpretation of what the regulatory language means and will replace the current guidelines in Appendix PP for F329, F330, and F331.The Investigative Protocol replaces the Investigative Protocol for Adverse Drug Reactions (ADR) currently in Appendix P.
2Overview of New Guidance Not about medications, it’s 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.
3Overview 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; it’s good resident care.Remember, the regulations haven’t changed, the descriptions or interpretive guidelines have.Start learning about the guidance and begin implementing changes.Expect more changes, revisions in the future.
4Coordination & 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 proceduresConsidered 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.
5Coordination & 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…”
6Coordination & 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])”
7F329 What’s Changed? Only the Guidance has changed. Increased information on indication, monitoring, adverse consequences for broader range of types of medicationsModification of Gradual Dose ReductionInclusion of tapering
8F425, 428, 431 What’s Changed? Only the Guidance has changed. Increased information on what is pharmaceutical services.Increased information about Medication Regimen Review.
9Development of the Guidance Pharmacy Services and Unnecessary MedicationsInvolved 2 separate expert panels for both the pharmacy services tags and unnecessary medication tagsReleased for 1st public comment period - October 20041st Comment period ended - January 2005Expert panels reconvened - April 2005Due to significant number of comments received during 1st comment period and subsequent revisions, a 2nd draft was released September 2005Expert panels reconvened again - December 2005/January 2006Final documents released - September 15, 2006Effective date/implementation scheduled for DECEMBER 18, 2006
10Tags Combined Unnecessary Medications Pharmaceutical Services New Tag F329 = Old Tags F329, F330, F331Unnecessary DrugsPharmaceutical ServicesNew Tag F425 = Old Tags F425, F426, and F427 (b) (1)Pharmaceutical Services, Procedures, ConsultationNew Tag F428 = Old Tags F428, F429, F430Medication Regimen Review (DRR)New Tag F431 = Old Tags F427 (b) (2) and (3), F431, F432Control, Labeling, and Storage
11F329 Unnecessary Medications Interpretive GuidelinesNotes:Introduce yourself and the other presentersWelcome the participantsProvide logistical information such as location of restrooms, vending machines, etc., as appropriate.Message:Today, as we discuss Unnecessary Medications, you will note that we have used the term medications rather than drugs throughout this Guidance. The term “medications” is consistent with the regulatory provisions and has a more positive connotation. There are, however, instances where the term drug has been retained because it has become part of standard nomenclature, such as Adverse Drug Reaction.
12Medications and Long-Term Care Medications are an integral part of long-term and subacute careCan improve function and quality of lifeCan help attain various outcomes, for exampleCuring acute illnessDiagnosing disease or conditionArresting or slowing disease processReducing or eliminating symptomsPreventing 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)
13Scope of the ProblemMedications are also a known public health problemDescribed in the medical, nursing, and pharmacology literature for many decadesDiscussed repeatedly in the mass mediaRelevant in every setting
14Source: Parade Magazine, March 12, 2006 AMDA strives to promote a balanced approach to medical care, including the notion that there can be too much of a good thing.Increasingly, the public is being warned about that, but they may not know how to distinguish the prudent from the risky.Take, for example, this report in this past Sunday’s issue of Parade Magazine. While it notes that medications are often beneficial, it also states, “Assume any new symptom is related to a drug, even if it bears no relation to why you’re taking it” and “Be careful that you’re not being prescribed medicine for a condition caused by another drug.”
15Drug-Related Problems (Categories) 1. A medical indication for the drug2. Too little of the correct drug3. Too much of the correct drug4. Incorrect drug5. Medical problem secondary to adverse drug reaction6. Drug-drug, drug-food, drug-lab test interactions7. Medical problem due to patient not receiving drug8. Medical problem resulting from a drug for which there is no valid medical indication
16Not a New ConcernJ 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
17Economic Impact of Diseases Affecting Americans Age 65 and Older If adverse reactions to medications were classified as a disease, it would rank as the 5th leading cause of death in the U.S.CV Disease $171 BillionCancer $104 BillionAlz. Disease $100 BillionDM $92 BillionMedication-Related Problems $66.2 BillionJAMA April 1998
19Overview 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 admission6 X that of general population
20Medication Adverse Consequence Adverse drug reaction-Side effect-Toxic effect-Hypersensitivity-Idiosyncratic-Adverse medication interactionMedication-Food interactionMedication-Disease interaction50-80% of adverse consequences are potentially avoidable without reducing therapeutic effects of medications. (Predictable)
21“Allergic”/Adverse Drug Reactions Brief description of reactionDate of occurrence Drug Reaction (date) Aspirin g.i. upset Amoxicillin hives, itch (8/94) Erythromycin diarrhea (9/89) Haldol stiff neck/jaw (3/92)
22Study in 2 academic-based nursing homes Most frequent causes for the preventable adverse consequences:Inadequate monitoringFailure to act on monitoringErrors in orderingWrong doseWrong medicationMedication-medication interactions
23Drug-Related Problems ConsequencesTreatment FailureNew medical problemSubsequent EventsPhysician revisitFurther RxUrgent care visitER visitHospital admitLTCF admitDeathNo further attention
24•$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- 8.7 million hospital admissions- 17 million ER visits>200,000 deaths/year due to ADRs.
25For every $1. 00 spent on drugs for nursing home patients, $1 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 2005:118:251-8.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
26Hx:. 81 yo female with mild HTN, OA, OP 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. wk Calcium w Vit D b.i.d. ASA E.C. 325 q.d. Vioxx 25mg q.d. Alprazolam 0.25mg t.i.d.prn Vicodin 1-2 q. 6 hr prn
277/17/04: 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
287/17/04: 1:00pm T.J. call to vendor pharmacy to obtain Rx history. -Alprazolam 0.25mg x /18/04, 3/11/04, 4/27/04, 6/3/04, 6/24/04, 7/14/04-Vioxx 25mg x 28 6/25/04-Vicodin x /14/041:30pm Physician arrives
29Etiology of Drug-Related Problems 1. 3 different prescribers2. Lack of pharmacist intervention3. Weakness, ataxia, impaired cognitionAlprazolam, Vicodin4. Elevated BPAntagonism of ACE Inhibitor (lisinopril) antihypertensive effect by Vioxx as well as possible Vioxx-induced HTN.5. HyponatremiaPossibly Vioxx and HCTZ
307/18/04: 10am Discharged after 40 hr hospitalization 1pm On dock at lake2pm Pontoon rideSpends rest of day enjoying children and grandchildren.7/23/04: Successful hip replacement surgery
32Medication Related Problem Expenses: -Telemetry $1,770/d x 2 days-ER Room $1,949.50-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.
33Hospitalization Bill for 40 hour admission $13,198.50
34F329 IntentSelect medications based on assessing relative benefits and risks to individualEvaluate individual’s signs and symptoms to identify underlying causes, including adverse consequencesSelect and use of medications in doses and for duration appropriate to individual’s clinical conditions, age and underlying causes of symptomsUse of non-pharmacological interventions, when applicable, to minimize need for medications, permit use of lowest possible dose, or allow discontinuation of medicationsMonitor efficacy and clinically significant adverse consequences of medications
36Unnecessary Medications (1) General. Each resident’s 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.Message:Like many of the other long term care requirements, this Unnecessary Medications regulation focuses attention on the individual resident and not on the facility’s population as a whole.Although much of the discussion in the Guidance centers on the older individual, the requirements of this regulation are applicable to the use of medication by each resident, regardless of age.The regulatory text addressing Unnecessary Medications is divided into 2 major components: General and Antipsychotics.
37Unnecessary Medications (2) Antipsychotic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that—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.Message:The 2 requirements specific to the use of antipsychotic medications used to have separate tag numbers (F330 and F331), but all the requirements regarding Unnecessary medications have now been folded into the F329 tag.The requirement regarding not initiating an antipsychotic agent unless the antipsychotic is necessary to treat a specific condition mirrors the considerations used for identifying indications for use of any other medication. Therefore, we have not repeated that guidance specifically for the use of antipsychotic medications but have incorporated antipsychotic medications in the general guidance regarding indications for use.
38DefinitionsAdverse consequence - is an unpleasant symptom or event that is due to or associated with a medication, such as impairment or decline in an individual’s 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 - 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 resident’s distressed behavior.Message:“Adverse Consequences” is the term used in the regulatory text. Adverse drug reaction and side effect were the terms most frequently used in some of the previous Guidance. While Adverse Consequence incorporates the concept of Adverse Drug Reaction (ADR), it is a broader concept than ADR. An adverse consequence may include, for example, a fracture that occurred as a result of a fall that was likely associated with the use of medications, such as medications that cause clinically significant orthostatic hypotension, dizziness, muscular incoordination and so forth.Although a side effect may be a type of ADR, it does not necessarily rise to the level of an adverse consequence. In fact, some prescribers will order certain medications specifically for their known side effects, for example, antidepressants with sedative properties. Unless the medication has a negative impact upon the resident, the side effect would not meet the definition of an adverse consequence.
39DefinitionsClinically significant - refers to effects, results, or consequences that materially affect or are likely to affect an individual’s 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.Message:“Clinically significant” is a new definition and is intended to separate out positive and negative issues or items of importance from those that are insignificant or a minor consequence or nuisance.
40DefinitionsIndications for use - is the identified, documented clinical rationale for administering a medication that is based upon an assessment of the resident’s condition and therapeutic goals and is consistent with manufacturer’s 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.Message:A diagnosis alone without substantiating information in the record is not necessarily justification for the use of a medication. For example, adding a diagnosis of schizophrenia next to an order for an antipsychotic, or GERD next to an order for a protein pump inhibitor (PPI) when there is no supporting documentation that substantiates the diagnosis, does not meet the regulatory requirement regarding Indications for Use.Another example could be a resident who is receiving a medication for which the resident has a known allergy. In this case, there should be documentation of an evaluation that indicates that the benefit of the resident receiving the medication exceeds the risk. This would indicate the appropriate consideration of the medication.On some occasions, medications may be considered as meeting the requirements for Indications for Use based on clinical standards of practice. For example, prophylactic use of low-dose aspirin, pneumonia vaccine, or annual flu vaccines, when there are no contraindications, would meet the requirement.
41DefinitionsMonitoring - 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 individual’s 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; andSupport decisions about modifying, discontinuing, or continuing any interventions.Psychopharmacologic medications - any medication used for managing behavior, stabilizing mood, or treating psychiatric disorders.Message:Monitoring involves several levels of evaluating the resident.The initial level of recognition may involve staff such as nursing assistants, dietary staff, physical therapist, or activities staff, who have an awareness of the resident and his or her usual patterns and level of functioning, and who could report any positive or negative changes.The next level of monitoring involves a more in-depth evaluation of those observations or information by staff such as physicians and nurses.
42Non-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 resident’s 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.
43OverviewNon-pharmacological approaches require assessing and understanding causes for need of medicationABC’s: Antecedent…..Behavior….Consequence.Approaches involve reduction/elimination of impediments, triggers and causesExamples of Non-Pharmacological Interventions:Modification of environmentModification/elimination of psychological stressorsAccommodation of previous lifelong activities or rolesModification of staff/resident interactionsBehavioral InterventionsMessage:As a surveyor, you would expect that the interdisciplinary team and the pharmacist, have collaborated with the physician and or other prescribers, to determine, to the extent possible, the root cause of the condition, symptom, or disease which has lead to considering the use of a medication. As part of that analysis, contributing factors and triggers are identified and in some situations, non pharmacological interventions may have been used instead of pharmacological interventions to address the issues.For example, if a resident has insomnia, have underlying contributing factors been considered, such as a caffeine intake in the late afternoon or evening, procedures that interrupt sleep, or the presence of excessive noise, variations in temperatures, such as too hot or too cold, and so forth.Or if a resident has joint or muscle pain, have underlying causes and related factors such as the level of activity, or positioning or arthritis been considered?What about the resident who may have episodic verbal or physical outbursts, was there an evaluation for the triggers to that behavior?
44Medication Management Resident Choice & Advance DirectivesIndications for UseMonitoringDoseDurationTapering/ Gradual Dose ReductionAdverse ConsequencesMessage:The Medication Management discussion is the heart of the document and provides guidance for understanding the various regulatory considerations regarding unnecessary medications.There are numerous places in the clinical record where information about aspects of the care process related to medications may be found. We don’t require information to be in any particular location within the record. If there is difficulty locating information during a survey, the surveyor should ask the facility for assistance in locating the information.The attending physician has a key leadership role in developing, monitoring and modifying the medication regimen and non-pharmacological interventions. The physician works with the resident and/or the resident’s representative, other professionals and direct care staff who advocate on behalf of the resident and who identify, assess, monitor, and communicate the resident’s needs, goals, and changes in condition.
45Medication 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 residentTheir representativesOther professionalsDirect care staff
46Promoting Care Process F329 notes that medication management is based in the care processRecognition or identification of the problem/need/riskAssessment (gathering details)Diagnosis/cause identificationManagement/treatmentMonitoringRevising interventions, as warranted
47Strategies: Care Process Advise prudent “disease management”Must be in contextNeeds a sound biological basisHard to isolate targeted organsOften invokes the “law of unintended consequences”
48The “Cascade Effect”Symptoms (including those related to medications often part of a cascade of problemsMedication lethargy decreased oral intake fluid/electrolyte imbalance further lethargy weight loss skin breakdownPneumonia confusion medication lethargy skin breakdown
49Medication Management Members of the interdisciplinary team participate in the care process by:identifying, addressing, advocating for, monitoring, and communicating the resident’s needs and changes in condition.Selecting medications and non-pharmacological interventions
50ChallengesNonpharmacologic interventions can be contrary to the instincts of some physicians, consultant pharmacists, and nursesOften require somewhat more time for staff to deliver, practitioners to identifyPromoting a patient-centered approachThe “easy way out” is often harder on the patientMedications should not constitute “path of least resistance”
52Clinical Strategies: Key Principles Respect for basic biologyGood / Patient-CenteredCoordinated 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.]
55Strategies: Multiple Prescribers Next day or Monday review of medications prescribed during nights and weekendsFollow-up with attending physician of questionable orders, undefined symptoms, high-risk medicationsEmphasize 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)
56Strategies: Medications and Related Risks Promote use of references about how to care for patients with various conditions that may require medicationsBooks, monographs, articles, PDR, etcPertinent clinical protocols and guidelinesEffective application of current standards of practiceComputer-based resourcesProvide FDA / manufacturer warnings
57Compliance Strategies Encourage relevant patient-specific documentation to explain decisionsNot 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
58Strategies: Promote Pertinent Documentation What should be documented?How did we identify the symptomHow 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)?
59Documentation 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?
60Regarding Medications, Good Intentions Alone Are Not Enough
61Where in the clinical record would you look to obtain information about a resident’s medication regimen?
62Location of Information Hospital discharge summaries & transfer notesProgress notes & interdisciplinary notesHistory & physical examinationsResident Assessment Instrument (RAI)Plan of careLab reportsProfessional consultsMedication ordersMedical Regimen Review (MRR) reportsMedication Administration Records (MAR)
63Six Medication Management Considerations Indications for use of medicationMonitoring for efficacy & adverse consequencesDoseDurationTapering/gradual dose reduction (GDR)Prevention, identification & response to adverse consequences
65Indications for Use of Medication Indications require evaluation of information such as:Co-morbid conditions, signs, and symptomsGoals and preferencesAllergies, potential interactionsPast and current medications and interventionsRecognition of need for end-of-life or palliative careRefusal of care and treatmentAssessment instruments and diagnostic toolsMessage:Indications for:Initiating;Continuing;Withdrawing a medication; orWithholding or modifying dosages;are determined by assessing the resident’s underlying condition, symptoms, and preferences.An evaluation may include a variety of diagnostic tools and tests which establish a baseline and help determine diagnoses and prognoses. The extent of the evaluation may vary with the situation, such as whether the medications are being re-ordered or are the result of a condition change or decline.
66Indications for Use of Medication Analysis is used to:Rule out other causes of symptomsIdentify whether signs/symptoms are significant/persistent to warrant medicationDetermine if the medication addresses symptom/conditionIdentify whether the benefits outweigh risksMessage:Analyzing the data collected is an integral aspect of assessment. Analysis helps determine, to the extent possible, causes of symptoms that may or may not be disease related or that are caused by a disease not originally suspected. It helps clarify the clinical rationale or necessity for a medication (and potentially for non-pharmacological interventions). It also helps determine which medication and what dose offers the most benefit with the least risk.The regulation does not prohibit “off-label use” or the use of medications for indications other than those indications originally approved by the FDA. For example, some anticonvulsants and some antidepressants have been prescribed to treat chronic pain. To justify the necessity for those medications, the facility should be able to refer to or provide clinical practice guidelines or published, peer-reviewed clinical studies supporting the off-label use. Table 1 provides additional discussion regarding indications for use and documentation recommendations for a number of medications. The newly revised guidance addresses indications for use of antipsychotics both for approved and off-label uses.
67Unnecessary Meds General Diagnosis alone may not warrant treatment with medicationPRN meds - important to evaluate and document:Indication(s)Specific circumstances for useFrequency of administrationOrders from multiple prescribers can increase resident’s chances of receiving unnecessary medsAlthough the guidelines generally emphasize the older adult resident, adverse consequences can occur at any age; therefore, these requirements apply to residents of all ages
68Indications for Use of Medication What do these 5 circumstances have in common?A clinically significant change in condition/statusA new or recurrent clinically significant symptomA worsening of an existing problem or conditionAn unexplained decline in function or cognitionPsychiatric disorders or distressed behaviorAsk discussion questionAnswer:We would like to focus on couple of common elements. First, each of these circumstances may be directly related to the use of one or more medications. The interdisciplinary team, including the prescriber, should evaluate the role of the medication regimen as a contributing factor before another medication is added to address a condition, problem or symptom.A second common element underlying at least the first four of these conditions is that each of the conditions has involved some degree of change from a baseline condition. It is important, therefore, that the resident’s condition be monitored in order to identify these changes and allow a reevaluation of the resident’s condition, as soon as possible. Some of the long-term psychiatric diagnoses may not have involved a change, but other psychiatric conditions may represent a change, such as delirium or exacerbation of an enduring psychiatric disorder.Message:There may be other circumstances when the resident’s condition and proposed medications are evaluated including admission or readmission, a new medication order or renewal of orders, medications ordered by multiple prescribers, or an irregularity identified by the pharmacist during the medication regimen review (MRR).
69What information would you consider when evaluating indication for use?
70Information Mental, physical, psychosocial & functional status Goals & preferences of the resident/designated representativeAllergiesHistory of prior & current medications and non-pharmacological interventionsRecognition of need for end-of-life or palliative careRefusal of care & treatmentRAPS
71Case ScenarioMs. 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 diseaseSuspected s/s ischemic MIDementia, history of seizuresCare plan for mood and behavior, bowel & bladder incontinence, and weight loss.
72Case ScenarioDuring 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.
73Case Scenario Labs Weight K+ = 3.6 (on admission) TSH = 2.5 (on admission)Weight110 lbs (on admission)97 lbs (6 months later)
74Case ScenarioOlanzapine (Zyprexa) 5mg at bedtime for behaviors (yelling, and refusing care)Lorazepam (Ativan) 2mg vial IM for seizure activityLorazepam (Ativan) 0.5mg for anxiety manifested by restless movementTemazepam (Restoril) 7.5mg at bedtime as needed for sleepPhenytoin (Dilantin) 100mg at 8am, and 200mg at 5pmKCL elixir 20mEq at 8amLevothyroxine (Synthroid) 100mcg dailyRantidine (Zantac) 150mg daily for GI distressDonepezil (Aricept) 5mg dailyIsosorbide Dinitrate 20mg one tablet three times daily for anginaMegesterol acetate (Megace) 800mg daily to increase appetiteAtenolol (Tenormin) 50mg dailyASA 25mg/dipyridamole 200mg)(Aggrenox) one cap daily
75Clinical “Triggers” Admission or readmission Clinically significant change in condition/statusNew, persistent or recurrent clinically significant symptom or problemWorsening of existing problem/conditionUnexplained decline in function or cognitionNew medication order or renewal orderIrregularity in pharmacist’s monthly medication regimen reviewMultiple prescribers
76Physician Orders CLARIFY CONFUSING ORDERS CLEARLY MARK STOP DATES AVOID OPEN ENDED ORDERSAVOID DOSAGE RANGESCAREFULLY TRANSCRIBE HOSPITAL DISCHARGE ORDERSMAKE SURE ORDERS WITH PARAMETERS ARE FOLLOWEDMAKE SURE LABS ARE DONE AS ORDEREDCHECK FOR DRUG ALLERGIES PRIOR TO ORDERING FROM PHARMACY OR TAKING A MED FROM EMERGENCY KITINFORM PRESCRIBER OF FREQUENTLY REFUSED DOSES
77Faxing to Physicians INCLUDE PERTINENT AND CURRENT MEDICATIONS INFORM OF PRN MEDICATION USE*FREQUENCY*EFFECTIVENESSCLEARLY LIST SYMPTOMS, VITAL SIGNSHOW LONG SYMPTOMS PRESENTBE SPECIFIC ON YOUR DESIRED OUTCOME
78[FAX] Concern: Loretta in ER last night for epistaxis [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?
79Response by Physician: T#3 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.
80Response 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?
812nd Repsonse by Physician: D/C Toprol 2nd Repsonse by Physician: D/C Toprol. *Would be nice to see med sheets when asking the [question] “Any changes?”My memory can’t keep track of everyone’s meds (How is BP today? Better? ?HA better with pain meds)
82[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 CEA’sAtivan 0.5 mg po q 6° prn15 mg qd
83[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[FAX] For Your Information: Resident is receiving Ativan 0 [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?
85Discussion (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)
86Indication Considerations include whether…. An appropriately detailed evaluation/assessment has occurredOther causes of symptoms have been ruled outSigns, symptoms are persistent or clinically significant enough to warrant medication useNon-pharmacological interventions were consideredParticular medication is indicated to manage that symptom/condition
87Indication Considerations include whether…. Intended or actual benefit justifies potential risksResident’s goals and preferences (inc. end-of-life needs) have been consideredResident has allergies to the medication or the potential for interactionsEffectiveness and adverse consequences from previous and current therapy have been considered
88IndicationResident 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?
89QuestionWhich of the following is NOT an appropriate indication for an antipsychotic?A. DeliriumB. Depression with psychotic featuresC. Schizoaffective disorderD. Wandering
90Summary Indication for Use: Evaluation of resident helps to identify needs, comorbid conditions & prognosis to determine factors that are affecting signs, symptoms and test resultsClinical “triggers” warranting evaluation
92Monitoring for Efficacy & Adverse Consequences Steps in MonitoringIdentify information and how it will be obtained and reportedDetermine frequencyDefine method to communicate, analyze and actRe-evaluate and updating approachesMessage:Processes the facility may utilize when developing the criteria for monitoring medications include;Identifying what information is to be collected, who will be responsible for collecting the information, and how and where it will be recorded;Determining the frequency for the periodic planned evaluation of progress toward the therapeutic goals or screening for emergence of adverse consequence, which depends largely on factors we’ve discussed previously such as the resident’s condition and the pharmacologic properties of the medication;Defining who will communicate with the prescriber, what information should be conveyed, and when to ask the prescriber to reevaluate the medication regimen and consider modifying the regimen; andRe-evaluating and updating monitoring approaches when indicated, such as when the resident experiences changes, the medication regimen or care and services has changed or there are changes in the product specifications or FDA warnings.
93Monitoring for Efficacy & Adverse Consequences Sources may help to define monitoring criteria:Manufacturers’ package inserts, black-box warningsFacility policies and proceduresPharmacistsClinical guidelines or standards of practiceMedication referencesPublished clinical studies or articlesMessage:There are many resources available for establishing the criteria for monitoring. Monitoring parameters need to be based on the resident’s condition, the pharmacologic properties and associated risks of the medication being used, the individualized therapeutic goals, and the potential for clinically significant adverse consequences.Some medications may be monitored using serum medication concentrations. The characteristics of some medications such as warfarin or vancomycin, which have limited ranges of safety, rely substantially on the serum medication concentrations or related results (For example - PT/INR). It is important to note that the levels of some other types of medications need to be reviewed in relation to the clinical presentation of the resident, such as the presence of seizure activity in a resident taking anticonvulsants.Not all medications need to be, nor should they be, listed on the resident’s care plan. In general, they are best addressed by incorporating them into the plan to manage the issues, conditions or risks for which they are being prescribed, for example, diabetes or pain. Those that are relevant to include are those, for example, that have black box warnings, or which have the risk for clinically significant adverse consequences, such as warfarin, digoxin, antidepressants, amiodarone or antipsychotics.If the facility has a written protocol or procedure addressing the monitoring specific to one of more of the medications the resident is receiving, the care plan may refer the care givers to that protocol, if the protocol is readily available within that unit, and in those cases, it is important to evaluate if those protocols are being implemented for the resident being reviewed.
94Monitoring for Efficacy & Adverse Consequences Review Psychopharmacological and Sedative/Hypnotic medications quarterlyDocumentation must include:Resident’s target symptoms and effect of medicationChanges in resident’s functionMedication-related side effects or adverse consequencesMessage:The interdisciplinary team should be reviewing each resident’s medication regimen at least quarterly, including whether there is a need to continue the use of psychopharmacologic and sedative/hypnotic medications, and whether the dose continues to be appropriate.Part of that review would include the effect of the medication on the severity, frequency, and other characteristics of the target symptoms; whether there have been any changes in the resident’s function during the previous quarter; and whether the resident has experienced any medication-related adverse consequences during the previous quarter.For example, the team would look at whether the resident’s function has declined as a result of falls that may be associated with the prescribed medications or whether sleep hygiene techniques have been successfully implemented and the resident may be able to tolerate less frequent use or elimination of sedatives/hypnotics. Additionally, the review should evaluate whether the use of the medications is consistent with the current standards of practice, relevant clinical practice guidelines and/or manufacturer’s specifications.
95Importance of Monitoring Tracks progress towards therapeutic goalsDetects emergence or presence of any adverse consequencesBENEFITRISK
96Monitoring Parameters Resident’s conditionPharmacological properties of medication & its risksIndividualized therapeutic goalsPotential for clinically significant adverse consequences
97Monitoring What is the purpose of monitoring? To incorporate medication-related goals and monitoring parameters into the resident’s comprehensive care planIn some cases, can refer to facility’s established protocols or P+PsTo optimize med therapy (BENEFITS) while minimizing adverse consequences (RISKS)To establish parameters for evaluating the ongoing need for the medicationsTo verify or differentiate the underlying diagnoses/causes of signs and symptoms
98Monitoring What are the steps or components of monitoring? Identify the essential information and how it will be obtained and reportedDetermine the frequency and duration of monitoringDefine the methods for communicating, analyzing, and acting upon relevant informationRe-evaluate and update monitoring approachesUsing QUANTITATIVE and QUALITATIVE monitoring parameters facilitates consistent and objective collection of info by facility
99Examples of tools used for determining 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, HgbA1CResident Assessment Instrument (RAI)Minimum Data Set (MDS)Pain scalesPhysical Self Maintenance Scale (PSMS)Functional Alzheimer’s Screening Test (FAST) scaleMini-Mental Status Exam (MMSE)Confusion Assessment Method (CAM)Instrumental Activities of Daily Living Scale (IADL)Abnormal Involuntary Movement Scale (AIMS)
100Examples of tools used for determining 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 ScaleMania Rating ScaleBehaviorBehavioral Pathology in Alzheimer’s Disease Rating Scale (Behave AD)Cohen-Mansfield Agitation Inventory (CMAI)Neuro-psychiatric Inventory-Nursing Home Version (NPI-NH)
101Case ScenarioMs. 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.
102Case Scenario Medications Aspirin 325mg daily for prevention Naproxen 500mg twice daily for painLisinopril 30mg daily for hypertensionAlendronate 70mg weekly for Osteoporosis
105Dose influenced by:Tables/Drug References provide general guidance on dosesResident parameters (renal, hepatic, weight)Current condition, signs and symptomsCo-morbid conditionsType of medicationTherapeutic goalsClinical responseConcurrent medicationsPossible adverse consequencesRoute of administrationInputs from interdisciplinary teamMessage:A prescriber’s order for the dose of a medication is based on a variety of factors including the resident’s diagnoses, signs and symptoms, current condition, age, lab and other test results, input from the interdisciplinary team about the resident, coexisting medication regimen and the type of medications, and therapeutic goals.It is important to remember when reviewing the doses prescribed that many medications have not been tested on individuals with the advanced age or conditions of the nursing home populations and that adverse consequences can occur even if the dose received is within the manufacturer’s specifications and relevant clinical practice guidelines.Routes of administration affect the amount or dose of a medication received and require compliance with the manufacturer’s guidelines for use. For example, the dose the resident receives from a fentanyl patch will be affected by the integrity of the patch and whether there is any additional heat or cold in the area of the patch. Doses may also be affected by the rate of an IV drip or crushing or chewing a sustained release oral capsule or tablet.
106Dose influenced by:Lab tests (i.e., serum medication concentrations) are only rough guideSignificant adverse consequences can occur even with lab results are within therapeutic rangeLab results alone warrant evaluation, but do not necessarily warrant dose adjustmentOther test resultsTherefore, …………….…………………………………..
107The same dose of a medication given two different people may cure one and harm the other. (2-edged sword)
109Duplicate TherapyUse of 2 or more medications from the same therapeutic class or the use of medications with similar effects from several classesGenerally not indicatedClinical rationale (because of different mechanisms, synergism, standards of practice) may result in justification to reach therapeutic goals, but needs to be monitoredPotentially can increase the risk of adverse consequences
110Duplicate Therapy Duplicate therapy examples… Acetaminophen-containing productsMultiple laxativesMultiple benzodiazepinesAnticholinergic effectsDocumentation is necessary to clarify rationale for, benefits of, and monitoring of duplicate therapy
111Dose/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.
112SummaryDose:Influencing factors - clinical response, possible adverse consequences, diagnosis, signs & symptoms, current condition, age, coexisting medication regimen, lab & other test results, therapeutic goals, type of medicationRoute of administrationDuplicate therapy generally NOT indicatedDosage Tables & Drug Interaction Table job aids
114DurationLooking at resident conditions are medications being used for the appropriate time frames?Is condition still present?Acute vs. Chronic
115Importance of Duration Many conditions require treatment for extended periods, while others may resolve and no longer require medicationExcessive Duration may lead toIncreased risk of adverse consequencesIncreased risk of medication interactionsAntibiotic resistanceInadequate Duration of Treatment may also lead to treatment failure
116Duration Some meds needed for extended periods, others shorter-term Acute conditionsCough/ColdNausea/VomitingAcute PainPsychiatric/Behavioral SymptomsIf stop date according to facility P+P, discontinuation should occur - otherwise document clinical rationaleClinical rationale for continued use of a medication may have been demonstrated in clinical record, or staff/prescriber may present clinical rationale
117Summary Duration: Periodic re-evaluation necessary Clinical rationale for continued use may be demonstrated in clinical recordStaff or prescriber may present pertinent clinical reasons
118Tapering of Medication Dose/Gradual Dose Reduction (GDR) for Antipsychotic Medications
119Tapering/GDR Goals of Tapering or Gradual Dose Reduction (GDR): Determine lowest effective doseDiscontinue medication that is no longer needed or of benefit to the residentMinimize exposure to increased risk of adverse consequencesMessage:The guidance defines Gradual Dose Reduction as “the stepwise tapering of a dose to determine if symptoms, conditions, or risks can be managed by a lower dose or if the dose or medication can be discontinued.”Tapering may be indicated when the resident’s clinical condition has improved or stabilized or the underlying causes of symptoms have resolved and the type of medication requires gradual reduction of the dose in order to avoid adverse consequences that may occur, if the medication is stopped abruptly.When a side effect is becoming troublesome or other medication-related adverse consequences may be emerging, the medication and dose should be evaluated to determine whether the dose can be reduced and still be effective or whether the medication should be discontinued.The timing and duration of attempts to taper any medication depend on evaluation of multiple factors, such as the resident’s condition, characteristics of the medication, the medication regimen as a whole, etc.
120Tapering/GDR Indicated when: Clinical condition improves or stabilizes Underlying causes of original target symptoms have resolvedNon-pharmacological interventions have been effective in reducing symptoms
122Factors to Consider Coexisting medication regimen Underlying causes of symptomsIndividual risk factorsPharmacological characteristics
123Tapering/GDR: “Real Impact” New classes of medications added to those needing taperingCategories of GDR: AntipsychoticsCategories of Tapering: Sedative Hypnotic, Other “Psychopharmacologic medications”.
124Behavior MonitoringSo, which med classes mention behavior monitoring? According to Table 1…AntipsychoticsBefore initiating or increasing for enduring condition, target behaviors must be clearly and specifically identified and monitored objectively and qualitativelyAnxiolyticsWhen used for delirium, dementia, and other cognitive disorders with associated behaviors, behaviors to be quantitatively and objectively documented
125Pharmacologic Behavior Management Often over-rated, over-utilized, and lacking adequate documentation.
126GDR/Tapering for Antipsychotics Old:The length of time before an antipsychotic dose reduction is attempted should be consistent with the condition being treatedFrequency 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
127GDR/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
128GDR/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 attemptsAfter 1st year,GDR annuallyGDR is clinically contraindicated if:
129Antipsychotic indication & GDR Contraindications Behavioral symptoms related to dementiaThe resident’s target symptoms returned or worsened after the most recent attempt at a GDR within the facility; ANDThe physician has documented the clinical rationale for why any additional attempted dose reduction at that time would be likely to impair the resident’s function or increase distressed behavior.
130Antipsychotic 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 resident’s function or cause psychiatric instability by exacerbating an underlying psychiatric disorder; OR
131Antipsychotic indication & GDR Contraindications Other psychiatric disorders (e.g., schizophrenia, bipolar mania, depression with psychotic features)The resident’s 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 resident’s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder.
132AntipsychoticsBW has been at the facility for the last 6 months. According to the physician order sheet (POS) the dose of the patient’s haloperidol was reduced approximately 3 months ago without any worsening of behavioral symptoms of dementia namely the hallucinations.
133Tapering for Sedatives/Hypnotics Old:Begin tapering after 10 days of continuous daily useFrequency: three times within 6 monthsTapering is clinically contraindicated if three attempts within the last 6 months led to a decline
134Tapering for Sedatives/Hypnotics New:For as long as a resident remains on a sedative/hypnotic that is used ROUTINELY and beyond the manufacturer’s 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)
135Sedatives/HypnoticsMH is an 82 yr WF who has been at the facility for the last 3 months. She is taking temazepam at bedtime.
136Tapering for “Psychopharmacological Meds” Old ONLY APPLIES TO BENZODIAZEPINES:Begin taper after 4 months of continuous daily useFrequency: twice a yearTapering is clinically contraindicated if two previous attempts within the last year led to a declineNo mention of tapering of other pharmaceutical classes mentioned in old guidelines
137Psychopharmacological 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…)
138Tapering for Psychopharmacological Meds New:Psychopharmacological meds now grouped together, so more than just benzodiazepinesWhat classes might this include or impact? According to Table 1….AnticonvulsantsAntidepressantsAnxiolytics - including buspirone, antidepressants
139Psychopharmacological 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.
140Tapering Clinically Contraindicated HypnoticsThe 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 resident’s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder; OR
141Tapering Clinically Contraindicated HypnoticsThe resident’s 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 resident’s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder.
142Psychopharmacological Medications Tapering Other Psychopharmacologic MedsThe 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
143Tapering Clinically Contraindicated Psychopharmacological MedicationsThe 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 resident’s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder; OR
144Tapering Clinically Contraindicated Psychopharmacological MedicationsThe resident’s 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 resident’s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder.
145Tapering and GDRWhen would the interdisciplinary team evaluate the resident’s response to medications and consider reduction or discontinuation of medications?Message:In addition to the required comprehensive assessments, when would you expect evaluation of the resident’s response to the medication(s) and consideration of whether reduction or discontinuation of medications is indicated?Answer to discussion question:During monthly medication regimen reviewDuring review of total care plan and renewing of ordersDuring quarterly MDS reviewWe’ve already discussed monitoring of psychopharmacological and sedative-hypnotic medications and the expectation for a quarterly review of necessity and dose.
146Tapering/GDROpportunities for evaluation of medication, in regards to duration/dose:Consultant Pharmacist’s MRRPhysician’s visit or signing of ordersDuring quarterly MDS reviewWhat to evaluate:Resident’s target symptoms and the effect of the medication on symptoms (e.g., severity, frequency)Changes in resident’s function during previous quarter (e.g., MDS)Whether resident experienced any medication-related adverse consequences during previous quarter
147The “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 dyskinesiaLess likely to induce withdrawal anxiety, insomnia, exacerbation of symptomsMore likely to result in achieving minimal effective dosePRN dosing can be part of taperingEducate nursing staff re: PRN use
148Summary Tapering/GDR: Tapering applies to ALL medications Regulations require attempted GDR only for antipsychotic medicationsFactors – coexisting medication regimen, underlying causes of symptoms, individual risk factors, pharmacological characteristics
149Prevention, Identification & Response to Adverse Consequences
150Adverse Consequences Increased Adverse Consequence Risk Advanced age Multiple co-morbid conditionsNumber of medicationsCertain pharmacologic classes
152Strategies: Adverse Consequences Promote system to anticipate, monitor for, recognize, act upon adverse consequencesUnanticipated decline, falls, confusion, anorexia, dizziness, lethargy, incontinence, etcMedication regimen gets discussed for every change of condition, new symptom, worsening of symptoms despite treatment, etc
153Adverse Consequences Delirium Common medication-related adverse consequenceIndividuals who have dementia may be at greater risk for deliriumDelirium is associated with higher morbidity and mortalityMessage:Delirium is one of the more frequent medication-related adverse consequences and significantly increases the risk for morbidity and mortality.Some of the classic signs of delirium may be difficult to recognize and may be mistaken for the natural progression of dementia, particularly in the late stages of dementia. For example, these signs may include fluctuating level of consciousness, increasing disorientation, and difficulty paying attention.Careful observation of the resident, review of the potential causes of the mental changes and distressed behavior, and appropriate and timely management of delirium are essential.
154Importance Adverse consequences related to medications are common! In a 2005 study, 42% of adverse drug events were judged preventableMost common omissions included:Inadequate monitoringLack of/delayed response to signs, symptoms, or laboratory evidence of medication toxicity
155Adverse Consequences Another study of 18 nursing homes reported that: 51% (276/546) of the adverse consequences were considered preventable72% (171/238) of those considered as fatal, life-threatening, or serious were preventable34% (105/308) of significant events were considered preventable
156QuestionAccording to the investigative protocol guidance, which of the following signs or symptoms may be associated with medications:DehydrationConstipationBruisingAll of the above
157Adverse Consequences Any medication can cause adverse consequences Considerations include…Following relevant clinical guidelines and/or manufacturer’s specifications for use, dose, duration, monitoringDefining appropriate indications for useDetermining that the residentHas NKA to the medicationIs not taking other medications, products, food that would be incompatibleHas no condition, history, or sensitivities that would preclude use of that medication
158Role 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
159SummaryPrevention, Identification & Responses to Adverse Consequences:Statistics demonstrate need & importanceTables I & II job aidsDrug Information Resources job aid
160Table I: Medication Issues of Particular Relevance Examples of categories of medications that:Have potential to cause clinically significant adverse consequencesHave limited indications for useRequire precautions in selection or useRequire specific monitoringMessage:Surveyors should note that the table is based on primary and tertiary pharmaceutical references but is not all-inclusive. Since information continues to evolve and new medications are regularly becoming available, current sources on indications, precautions, doses, monitoring, and adverse consequences should be referenced.Medications other than those listed in the table may present significant issues related to indications, dosage, duration, monitoring, or potential for clinically significant adverse consequences.Surveyors should also note that “the listed doses for psychopharmacological medications are applicable to older individuals. The facility is encouraged to initiate therapy with lower doses and, when necessary, only gradually increase doses. The facility may exceed these doses if it provides evidence to show why higher doses were necessary to maintain or improve the resident’s function and quality of life.”
161Table II: Medications with Significant Anticholinergic Properties Anticholinergic side effects are commonMedications in many categories have anticholinergic propertiesUse of multiple medications with anticholinergic properties may be particularly problematicMessage:Table II lists medications commonly associated with significant anticholinergic properties and potential adverse consequences, but the list is not all-inclusive.Any of the signs and symptoms identified in the table may be caused by any of the medications listed, combinations of those medications as well as by other medications with anticholinergic properties that are not listed. The Table is provided to assist surveyors to quickly recognize a potential anticholinergic effect and potentially an associated medication.
162TABLE 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. benefitsMedications mentioned are not meant to be absolutely contraindicated for every resident, but that the medication has the potential to be unnecessaryWhile Table 1 is 36 pages long, it does not include all categories nor all medications within a category
163TABLE I: Medication Issues of Particular Relevance Current (“old”) guidelines include daily dose recommendations for psychotropic medicationsPrevious drafts of revised guidance did NOT include dose examplesBut, final document includes Daily Dose Thresholds for:AntipsychoticsAnxiolyticsSedatives/Hypnotics
164Analgesics Acetaminophen Avoid >4 Gm/day, LFTs. NSAIDs Trial APAP alternative; interactions with ASA, anticoagulants, anti-platelet agents; risks for GI bleed, renal insuff, CHF; CNS effects with some NSAIDs.Opioids Shorter-acting agent trial before long-acting; avoid meperidine; ADRs.Pentazocine Limited efficacy; >ADRs.Propoxyphene Risks > Benefits.
165AntibioticsAll Confirmed/suspected infection. (e.g., not for asymptomatic bacteruria)Aminoglycosides, Renal Fn, serum levels IV Vanco to minimize ADRs.Nitrofurantoin Renal insuff (CrCl<60); ADRs (pulmonary, neuropathy).
166Anticoagulants, Anticonvulsants, Antidepressants Warfarin INRs; interactionsAnticonvulsants Duration based on indication; possible serum levels; ADRs on liver, bone marrow, derm., CNS, falls.Antidepressants Indication; 2 or >; duration; GDR/tapering; worsening Sx; interactions; ADRs (CNS, GI, falls, seizures, serotonin syndrome).MAOIs; TCAs BP-tyramine; antichol., etc.
173AntipsychoticsAnalysis of antipsychotic use by 693,000 Medicare nursing home residents28.5% received excessive doses32.2% lacked appropriate indications for use
174Antipsychotic medications DiagnosesSchizophreniaSchizo-affective disorderDelusional disorderMood disorder (Bipolar, depression with psychosis, etc.)Schizophreniform disorderPsychosis NOSAtypical psychosisBrief psychotic disorderDementing illness with associated behavioral symptomsMedical illness or delirium with manic or psychotic symptoms
175Antipsychotics: Additional criteria Symptoms are due to mania or psychosis; ORBehavioral symptoms present danger to self or others; ORSymptoms are significant enough that the resident experiences:Inconsolable or persistent distressSignificant decline in functionSubstantial difficulty receiving needed care
176Antipsychotics: Inadequate indications WanderingPoor self-careRestlessnessImpaired memoryMild anxietyInsomniaUnsociabilityInattention or indifference to surroundingsFidgetingNervousnessUncooperativenessVerbal expressions or behavior not due to conditions listed under appropriate indications and that do not represent a danger to the resident or others
183Cardiovascular medications Alpha blockers: significant hypotension and syncope with initial doses (slow titration); prazocin more CNS effectsACEIs: monitor K+, cough, renal failure, interactions that increase K+, angioedemaBeta blockers: bradycardia, dizziness, fatigue, bronchospasm, depression, acute heart failure decompensation, mask tachycardia of hypoglycemia, increased effects in hepatic dysfunction
184Cardiovascular medications Ca+Channel blockers: constipation, edema, avoid short-actingMethyldopa: risk > benefit, bradycardia, sedation, depressionDigoxin: Dx only includes CHF, AF, PSVT, Atrial flutterDiuretics: fluid-electrolyte imbalance, hypotension, urinary incontinence, fallsNitrates: HA, dizziness, lightheadedness, faintness, orthostatic hypotension
185Cholesterol lowering medications Statins: LFT monitoring, muscle pain, myopathy, rhabdomyolysis to kidney failureCholestyramine: absorption interactions with other co-administered medications, constipation, dyspepsia, nausea, vomiting, abdominal painFibrates: LFT and CBC monitoringNiacin: glucose and LFT monitoring, gallbladder disease, gout, flushing
186Cognitive enhancersCholinesterase inhibitors: evaluate continued use in advanced stages, cardiac conduction, insomnia, dizziness, N/V/D, anorexia, weight loss, caution in asthma-COPDMemantine: evaluate continued use in advanced disease, restlessness, distress, dizziness, somnolence, hypertension, HA, hallucinations, increased confusion
187Case ScenarioAD 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: Alzheimer’s disease for 2 years, new onset diarrhea over last 1 -2 months, osteoporosis
188Case Scenario Medications Donepezil 10mg in the evening Loperamide 2mg as needed for loose stoolsCalcium 500mg and Vit D 400 IU twice daily
191Gastrointestinal medications MetoclopramideRisk > benefitRestlessness, drowsiness, insomnia, depression, distress, anorexia, EPSE, seizuresPPIs, H-2 AntagonistsIndications based on clinical symptoms &/or endoscopyTrial alternate analgesics before use for NSAID gastropathyH-2’s: dosed per renal function; confusionCimetidine drug interactionsPPI’s: risk of Clostridium difficile colitis
192Glucocorticoids Document necessity for continued use Hyperglycemia, psychosis, edema, insomnia, HTN, osteoporosis, mood lability, depression
193Hematinics EPO Assess anemia etiology before use Monitor BP, serum Fe/ferritin, CBCExcess dose/durationPolycythemia, MI, strokeIronNot indicated for anemia of chronic diseaseJustify use >2months; >q.d.Baseline serum Fe or ferritin, periodic CBC
195Muscle relaxantsPoorly tolerated in elderly due to anticholinergic side effects, sedation, weaknessAvoid abrupt cessation because of possible seizures or hallucinationsUsage exception: Periodic use (1 x q. 3 months) for short duration (<=7days)
196Orexigenics (appetite stimulants) Assess and manage underlying cause of anorexia/weight loss firstMonitor efficacy at least monthlyMegesterol: fluid retention, adrenal insufficiencyOxandrolone: sexual side effects, fluid retentionDronabinol: tachycardia, orthostatic hypotension, dizziness, dysphoria, impaired cognition, falls
197Osteoporosis medications BisphosphonatesSpecific administration guideline adherenceEsophageal or gastric erosionPotential GI symptoms with corticosteroids, ASA, NSAIDs
198Platelet inhibitors ASA, Dipyridamole, Clopidogrel Thrombocytopenia, bleedingHA, dizziness, vomitingCaution with NSAIDs, warfarinTiclodipineRisk > benefit (neutropenia)N, V, D
202Thyroid medications Potential drug interactions affecting dosage Initiate at low dose, increase graduallyAssess thyroid function studies periodically
203Urinary incontinence medications Assess underlying cause and identify type of incontinence: select medications accordinglyAssess urinary symptoms periodicallyMonitor side effects
204Table II: Medications with Significant Anticholinergic Properties Anticholinergic side effects are commonMedications in many categories have anticholinergic propertiesUse of multiple medications with anticholinergic properties may be particularly problematicMessage:Table II lists medications commonly associated with significant anticholinergic properties and potential adverse consequences, but the list is not all-inclusive.Any of the signs and symptoms identified in the table may be caused by any of the medications listed, combinations of those medications as well as by other medications with anticholinergic properties that are not listed. The Table is provided to assist surveyors to quickly recognize a potential anticholinergic effect and potentially an associated medication.
213IntentThe facility maintains resident’s highest practical level of functioning and prevents or minimizes adverse consequences related to medication therapy to the extent possible, by providing:Licensed pharmacist’s review of each resident’s medication regimen at least monthly- More frequent based on resident condition & risks or adverse consequences related to current medicationsIdentification and reporting of irregularitiesAction taken in response to irregularitiesMessage:The intent of this regulation is that medications do no harm, but rather help the resident maintain or achieve his or her highest level of functioning, to the extent possible.To help achieve this, there must be a medication regimen review by a licensed pharmacist at least monthly for each resident.Depending upon the condition of the resident and the characteristics of the medications and risks for adverse consequences, a more frequent review may be necessary. If any irregularities are identified, they must be reported to the director of nursing and the attending physician and there must be action taken to address the irregularities.
214Overview Factors increasing the risk of medication related issues Multiple medications are often required to address conditions, leading to complex medication regimensTransitions, such as a move from hospital to nursing home – Medications may be added, discontinued or changedAdverse consequences can mimic symptoms of chronic conditions (aging process, new conditions)Message:It is important to note that many nursing home residents require multiple medications to address their conditions, leading to complex medication regimens. The resident who is receiving a large number of medications or who has a more complex medication regimen is at greater risk for an adverse medication-related consequence.Some adverse consequences may appear to be end stages of a disease process or the emergence of a new disease. It may be the pharmacist who recognizes or suspects and reports that a resident’s deterioration is potentially not the normal progression of a disease process, but is instead an adverse consequence.The 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, that risks and problems are identified and acted upon, and that medication-related problems are considered when the resident has a change in condition.
215Common Manifestations of Adverse Drug Reactions in the Elderly That May Be Incorrectly Interpreted as Signs of AgingConfusionDepressionLack of appetiteWeaknessLethargyAtaxiaForgetfulnessTremorConstipationDizzinessDiarrheaUrinary retention
217Cheney 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.
218Overview (continued) Reviews to help identify issues: Physician reviews orders and total program of care on admission and prescriber reviews at each visitNurse reviews medications when sending orders to pharmacy and/or prior to administering medicationsInterdisciplinary team reviews as part of the comprehensive assessment for the RAI and/or care planPharmacist reviews the prescriptions prior to dispensingPharmacist performs medication regimen review at least monthlyMessage:As you can see on the slide, there are a number of times during various phases of the care process, that issues or concerns regarding medication use may be identified and addressed.The pharmacist role in this part of the care process includes providing consultation to the facility and the attending physician(s) or prescriber, regarding the medication regimen. During the performance of the MRR, the pharmacist applies his/her understanding of medications and related cautions, actions and interactions as well as current medication advisories and information. The pharmacist is an important member of the interdisciplinary team and regulations prohibit the pharmacist from delegating the medication regimen reviews to ancillary staff.
219Sources of Information May include, but are not limited to:MARsPrescribers’ ordersProgress, nursing, consultants’ notes, H&P, discharge summariesRAI/MDSLab reportsForms/reports reflecting behavioral monitoring and/or changes in conditionQM/QI reportsAttending physician, facility staffInterviewing, assessing, and/or observing the residentAsk yourself, how many of these do I use and should I be using more sources or different types of sources than I am now?
220MRR 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, resident’s allergies, potential interactions/averse consequences?Is dose, frequency, route, duration consistent with resident’s condition, manufacturer’s recommendations, and applicable standards of practice?
221MRR ConsiderationsHas 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?
222MRR ConsiderationsHas physician/staff noted and acted upon possible medication-related causes of recent or persistent changes in the resident’s condition?………………… ……think “Geriatric Syndromes”Anorexia and/or unplanned weight loss, or weight gainBehavioral changes, unusual behavior patternsBowel function changesConfusion, cognitive decline, worsening of dementiaDehydration, fluid/electrolyte imbalanceDepression, mood disturbance
223MRR Considerations Dysphagia, swallowing difficulty Excessive sedation, insomnia, or sleep disturbanceFalls, dizziness, impaired coordinationGI bleedingHeadaches, muscle pain, generalized aching/painRash, pruritisSeizure activitySpontaneous or unexplained bleeding, bruisingUnexplained decline in functional statusUrinary retention or incontinence
224Location and Notification of MRR Findings The Pharmacist mustDocument identification of irregularityReport irregularity to attending physician or director of nursingTimeliness of notification depends on severityIf no irregularities found, pharmacist signs statement indicating suchMessage:The pharmacist’s findings of any irregularities are reported to the attending physician and director of nursing. If the irregularity represents the potential for or presence of a serious adverse consequence, immediate notification is indicated, such as in cases of bleeding in a resident who is receiving anticoagulants or in cases of possible allergic reactions to antibiotic therapy.The pharmacist’s findings identifying irregularities or documenting that no irregularities were found are considered part of each resident’s clinical record. If the reports of findings are not maintained in the active record, they must be maintained within the facility and be readily available for review. Establishing a consistent location for the pharmacist’s findings and recommendations is recommended.The pharmacist does not need to report a continuing irregularity monthly if the pharmacist considers the irregularity to be clinically insignificant or the physician has provided a clinically valid rationale for rejecting the pharmacist’s recommendation. In these circumstances, the pharmacist needs to reconsider annually whether to report the irregularity or to make a new recommendation.The interdisciplinary care team is encouraged to review the reports and to get the pharmacist’s input on resident problems and issues.
225Response to Irregularities Identified in the MRR Physician is not required to order recommended treatments unless he/she determines they are medically valid/indicatedIf recommendation requires physician intervention, then:Physician accepts and acts upon suggestionORPhysician rejects and provides explanation for disagreeingMessage:Throughout the guidance, a response from a physician regarding a medication problem implies appropriate communication, review, and resident management, but does not imply that the physician must necessarily order tests or treatments recommended or requested by the staff, unless the physician determines that those are medically valid and indicated.If there is the potential for serious harm and the attending physician does not concur with or take action on the report, the facility and the pharmacist should contact the facility’s medical director for guidance and possible intervention to resolve the issue. The facility should have a procedure to resolve the situation when the attending physician is also the medical director.For those recommendations that do not require a physician intervention, such as one to monitor vital signs or weights, the director of nursing or designated licensed nurse addresses and documents action(s) taken.
226Response to Findings Physician either: Accepts recommendation and acts, ORRejects the recommendation and provides a brief explanation, such as in a dated progress note“It is not acceptable for a physician to document only that he/she disagrees with the report without providing some basis for disagreeing.”For those direct care issues that do not require physician intervention, DON or designated nurse can address and document action taken
227Lack of Action or Rejection What about when MD does not act upon or rejects MRR report/recommendations and there is the potential for serious harm?Facility and CP should contact Medical Director, ORWhen attending and Medical Director are same, follow established facility procedure to resolve the situationNo specific timeframe provided for when a report that is not acted upon officially becomes delinquent or “not acted upon”
228Lack of Action or Rejection What about continuing to document an issue that the physician has disregarded or rejected?“Pharmacist does not need to document a continuing irregularity each month if it’s deemed to be clinically insignificant or there is evidence of valid clinical reason for rejection”“In these situations, pharmacist need only reconsider annually whether to report again or make new recommendation.”
229F428 - MRRDefinition 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” we’re preventing, identifying, reporting, and resolving…how are MRPs, med errors, and irregularities defined?
230Medication-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 useUse of a medication without identifiable evidence that safer alternatives or more clinically appropriate medications have been considered
231Medication-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 durationPresence of an adverse consequence associated with medication(s)
232Medication-Related Problems (cont.) Use of a medication without adequate monitoring- inadequate monitoring of response to med, or- inadequate response to findings/resultsPresence of or risk for medication errorsPresence of a clinical condition that might warrant initiation of medicationMedication interaction - “TOP 10 DIs in LTC”
234Medication ErrorsA medication error isn’t actually defined in document, but NCCMERP definition is:“A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.”(Source:
235Irregularities 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.”
236F428 - MRRGiven 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…”
237Frequency of Review Monthly or more frequently, depending on: the resident’s condition, andthe risks for adverse consequences related to current medicationsThis sounds alarming, but it is virtually the same as current survey guidelinesRemember, there was additional guidance related to this in F425
238Where to Conduct the Review Generally within facility because important info may be attainable only by talking to staff, reviewing “paper” chart, observing/speaking with residentBUT new technology (electronic health records) may permit the pharmacist to conduct some components of the review outside of the facility
239Notification of Findings Timeliness of notification depends on potential for or presence of serious adverse consequencesExamples include:- Bleeding resident on anticoagulants- Possible allergic reactions to antibioticCollaborate with facility to identify the most effective means of notification/documentationNotification/documentation may be done electronically
240Location of Findings Pharmacist’s findings are part of clinical record If not maintained within active clinical record, it must still be maintained within facility and readily availableFind balance between:Encouraging/facilitating other healthcare professionals to utilizeAllowing facilities flexibility in determining a consistent location that suits their needs
241Considerations 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 guidelinesMight be more prudent, on an individual basis, to evaluate past gradual dose reduction/tapering attempts when considering future attempts…don’t necessarily want the burden of managing dose reductions on a multitude of residents at one time
242Considerations 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 suchF425: “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”
244Definitions Pharmaceutical Services The process of receiving and interpreting prescriber’s 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; andThe provision, monitoring and/or the use of medication-related devices.Message:(previous slide discussion question) What is included in the concept of Pharmaceutical Services?.Answer:As you can see, the definition of pharmaceutical services involves not only the processes of medication administration, but the development of procedures that provide direction to facility staff in all aspects of handling and managing medications and medication related equipment. It also includes the pharmacist’s consultation regarding all aspects of pharmaceutical services within the facility.
245IntentFacility provides pharmaceutical services to meet the needs to residentsMedications and biologicalsServices of licensed pharmacistPharmaceutical services are coordinated within the facilityProcedures developed and implementation evaluatedPharmaceutical concerns and issues affecting residents and care are identified and evaluatedOnly persons authorized under state requirements administer medicationsMessage:The intent of this requirement is that:In order to meet the needs of each resident, the facility accurately and safely provides or obtains pharmaceutical services, including the provision of routine and emergency medications and biologicals and the services of a licensed pharmacist;The licensed pharmacist collaborates with facility leadership and staff to coordinate pharmaceutical services within the facility, and to guide development and evaluation of the implementation of pharmaceutical services procedures;The licensed pharmacist helps the facility identify, evaluate, and address/resolve pharmaceutical concerns and issues that affect resident care, medical care or quality of life such as the:Provision of consultative services by a licensed pharmacist between the monthly pharmacist’s visits, as necessary; andCoordination of the pharmaceutical services if multiple pharmaceutical service providers are utilized such as the vendor pharmacy, infusion services, prescription drug plans (PDP) or hospices.The intent of this requirement also provides for the facility to utilize only persons authorized under state requirements to administer medications.
246Overview Provision of Medications Services of a Pharmacist Timeliness/Availability to meet needs of each residentServices 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 ProceduresAcquiring - AdministeringReceiving - DisposalDispensing - Labeling/Storage, incl.Authorized personnel controlled substances
247Provision 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 transferCondition 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 supplyOrdered start time
248Pharmacist ServicesConsultant pharmacist’s 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 pharmaciesInfusion providerHospicePrescription Drug Plan (PDP)
249Pharmacist Services -Determine contents & monitor use of E-Kits -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
250Pharmacist Services-Establish procedures for Monthly Medication Regimen Review (MRR) (more on MRR in F428)Conducting monthly MRR for each residentAddressing expected time frames for conducting the review and reporting findingsAddressing the irregularitiesDocumenting and reporting results of the MMRAddressing MRRs for residents:anticipated to stay less than 30 dayswho experience an acute change in condition as identified by facility staff
251Pharmacist 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 physicianexpectations for the physician’s response and follow-up, andhow and where this information will be documented.”
252Pharmacist 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
254Labeling 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/directionsLabeling of multi-dose vials (e.g., expiration dates)
255Controlled 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)
256F425 - 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
257F425 - 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”
259Intent The facility, in coordination with the pharmacist, provides: Safe and secure storage and handling of all medicationAccurate labeling to facilitate safe administrationA system of records enabling reconciliation and accounting of controlled medicationsIdentification of loss or diversion of controlled medications minimizing the time between actual loss and the detection of the extent of lossMessage:The safe and secure storage and handling of medications includes:Accurate labelingStorage of medications in accordance with the manufacturers recommendations such as proper temperature controlsSecure storage including limiting access to the medications and safe disposition, of medications; andA system in place to account for and to minimize loss or diversion of all controlled medications and other medications subject to abuse.
260Labeling 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 prescribedIn other words, if there isn’t space for an entire label, still better have - at least - resident’s name on actual product container
261Labeling New Key Points For compounded IV preparations, label contains:Name and volume of solutionResident’s nameInfusion rateName and quantity of each additiveDate of preparationInitials of compounderDate and time of administrationInitials of person administering medication if different than compounderAncillary precautions, as applicableDate after which mixture must not be used (i.e., expiration date)
262Labeling New Key Points For OTCs in bulk containers (in states that permit), label contains:Original manufacturer’s OR pharmacy-applied label indicating:Medication nameStrengthQuantityAccessory instructionsLot numberExpiration date, when applicableIf resident-specific supply of OTC, label contains above plus resident’s name
263Access 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/cartSelf-administration…Important that the facility have procedures for the control and safe storage of medications for those residents who can self-administer
264Storage, 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.
265Controlled 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
266Controlled Medications Old vs. New Record of RECEIPT of ALL controlled medications with sufficient to allow reconciliation, specifying:Name and strength of medicationQuantityDate receivedResident’s 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.,MARProof-of-use sheetsDeclining inventory sheetsEmergency Kits….Don’t forget about controlled medications located in the emergency supply
267Controlled Medications Old vs. New Old: Periodic reconciliations should be monthlyNew: 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
268Controlled Medications Old vs. New Old: If they reveal shortages:Pharmacist and the director of nursing may need to initiate more frequent reconciliationsFacility may have to utilize proof of use sheets on all controlled drugs for all shiftsWhen the source of shortage is located and remedied, the facility may go back to periodic reconciliation by the pharmacistNew: If discrepancies in records are identified or loss has occurred:Consultant Pharmacist and facility develop and implement recommendations for resolutionReview and revise monitoring procedures, as necessary (e.g., increasing the frequency of reconciliation)