Minnesota’s Call To Action

Minnesota’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.

Overview 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.

Overview of New Guidance
Use an interdisciplinary approach with individualized care to monitor and manage all medications. Therefore an increased responsibility of facility, prescribers, consultant pharmacist, and dispensing pharmacy regarding medication management. Try not to be overwhelmed; 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.

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

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…”

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])”

F329 What’s Changed? Only the Guidance has changed.
Increased information on indication, monitoring, adverse consequences for broader range of types of medications Modification of Gradual Dose Reduction Inclusion of tapering

F425, 428, 431 What’s Changed? Only the Guidance has changed.
Increased information on what is pharmaceutical services. Increased information about Medication Regimen Review.

Development of the Guidance
Pharmacy Services and Unnecessary Medications Involved 2 separate expert panels for both the pharmacy services tags and unnecessary medication tags Released for 1st public comment period - October 2004 1st Comment period ended - January 2005 Expert panels reconvened - April 2005 Due to significant number of comments received during 1st comment period and subsequent revisions, a 2nd draft was released September 2005 Expert panels reconvened again - December 2005/January 2006 Final documents released - September 15, 2006 Effective date/implementation scheduled for DECEMBER 18, 2006

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

F329 Unnecessary Medications
Interpretive Guidelines Notes: Introduce yourself and the other presenters Welcome the participants Provide 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.

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

Scope of the Problem Medications are also a known public health problem Described in the medical, nursing, and pharmacology literature for many decades Discussed repeatedly in the mass media Relevant in every setting

Source: 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.”

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

Not a New Concern J Amer Bd of Family Practice, 95; 8: , Ackerman et al. “It is safe to assume that many of our nursing home patients are suffering from drug side effects, drug interactions, or both.” “Careful review and pruning of the medication list could be the single most important service the clinician can provide to his or her nursing home patients” Ann Internal Medicine, (10/92), Vol. 43, No.4, Beers et al. Inappropriate medication prescribing common in NHs

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

ILLNESS DRUG ADVERSE EFFECT MEDICATION DRUG INTERACTION

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

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

“Allergic”/Adverse Drug Reactions
Brief description of reaction Date of occurrence Drug Reaction (date) Aspirin g.i. upset Amoxicillin hives, itch (8/94) Erythromycin diarrhea (9/89) Haldol stiff neck/jaw (3/92)

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

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

•$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.

For 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

Hx:. 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

7/17/04: 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

7/17/04: 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 /14/04 1:30pm Physician arrives

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

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

COST ?$

Medication 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.

Hospitalization Bill for 40 hour admission
$13,198.50

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

Preserve Quality of Life

Unnecessary 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.

Unnecessary 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.

Definitions Adverse 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.

Definitions Clinically 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.

Definitions Indications 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.

Definitions Monitoring - is the ongoing collection and analysis of information (such as observations and diagnostic test results) and comparison to baseline data in order to: Ascertain the 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; and Support 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.

Non-pharmacological Interventions
Increasing the amount of resident exercise, intake of liquids and dietary fiber in conjunction with an individualized bowel regimen to prevent or reduce constipation and the use of medications (e.g. laxatives and stool softeners). Identifying, addressing, and eliminating or reducing underlying causes of distressed behavior such as boredom and pain. Utilizing music-aroma-pet therapy, etc. Using sleep hygiene techniques and individualized sleep routines; assess exercise, naps, caffeine, fluids, environment. Accommodating the 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.

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

Medication Management
Resident Choice & Advance Directives Indications for Use Monitoring Dose Duration Tapering/ Gradual Dose Reduction Adverse Consequences Message: 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.

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

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

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

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

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

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

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

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

Discipline-Centered Care

Resident/Patient-Centered Care

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

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

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

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

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

Regarding Medications, Good Intentions Alone Are Not Enough

Where in the clinical record would you look to obtain information about a resident’s medication regimen?

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

Six Medication Management Considerations
Indications for use of medication Monitoring for efficacy & adverse consequences Dose Duration Tapering/gradual dose reduction (GDR) Prevention, identification & response to adverse consequences

Indications for Use of Medication

Indications require evaluation of information such as: Co-morbid conditions, signs, and symptoms Goals and preferences Allergies, potential interactions Past and current medications and interventions Recognition of need for end-of-life or palliative care Refusal of care and treatment Assessment instruments and diagnostic tools Message: Indications for: Initiating; Continuing; Withdrawing a medication; or Withholding 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.

Analysis is used to: Rule out other causes of symptoms Identify whether signs/symptoms are significant/persistent to warrant medication Determine if the medication addresses symptom/condition Identify whether the benefits outweigh risks Message: 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.

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

What do these 5 circumstances have in common? A clinically significant change in condition/status A new or recurrent clinically significant symptom A worsening of an existing problem or condition An unexplained decline in function or cognition Psychiatric disorders or distressed behavior Ask discussion question Answer: 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).

What information would you consider when evaluating indication for use?

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

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

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

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

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

Clinical “Triggers” Admission or readmission
Clinically significant change in condition/status New, persistent or recurrent clinically significant symptom or problem Worsening of existing problem/condition Unexplained decline in function or cognition New medication order or renewal order Irregularity in pharmacist’s monthly medication regimen review Multiple prescribers

Physician Orders CLARIFY CONFUSING ORDERS CLEARLY MARK STOP DATES
AVOID OPEN ENDED ORDERS AVOID DOSAGE RANGES CAREFULLY TRANSCRIBE HOSPITAL DISCHARGE ORDERS MAKE SURE ORDERS WITH PARAMETERS ARE FOLLOWED MAKE SURE LABS ARE DONE AS ORDERED CHECK FOR DRUG ALLERGIES PRIOR TO ORDERING FROM PHARMACY OR TAKING A MED FROM EMERGENCY KIT INFORM PRESCRIBER OF FREQUENTLY REFUSED DOSES

Faxing to Physicians INCLUDE PERTINENT AND CURRENT MEDICATIONS
INFORM OF PRN MEDICATION USE *FREQUENCY *EFFECTIVENESS CLEARLY LIST SYMPTOMS, VITAL SIGNS HOW LONG SYMPTOMS PRESENT BE SPECIFIC ON YOUR DESIRED OUTCOME

[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?

Response 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.

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

2nd 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)

[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’s Ativan 0.5 mg po q 6° prn 15 mg qd

[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)

[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?

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

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

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

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

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

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

Monitoring for Efficacy & Adverse Consequences

Steps in Monitoring Identify information and how it will be obtained and reported Determine frequency Define method to communicate, analyze and act Re-evaluate and updating approaches Message: 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; and Re-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.

Sources may help to define monitoring criteria: Manufacturers’ package inserts, black-box warnings Facility policies and procedures Pharmacists Clinical guidelines or standards of practice Medication references Published clinical studies or articles Message: 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.

Review Psychopharmacological and Sedative/Hypnotic medications quarterly Documentation must include: Resident’s target symptoms and effect of medication Changes in resident’s function Medication-related side effects or adverse consequences Message: 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.

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

Monitoring Parameters
Resident’s condition Pharmacological properties of medication & its risks Individualized therapeutic goals Potential for clinically significant adverse consequences

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

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

Examples 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, HgbA1C Resident Assessment Instrument (RAI) Minimum Data Set (MDS) Pain scales Physical Self Maintenance Scale (PSMS) Functional Alzheimer’s Screening Test (FAST) scale Mini-Mental Status Exam (MMSE) Confusion Assessment Method (CAM) Instrumental Activities of Daily Living Scale (IADL) Abnormal Involuntary Movement Scale (AIMS)

Examples 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 Scale Mania Rating Scale Behavior Behavioral Pathology in Alzheimer’s Disease Rating Scale (Behave AD) Cohen-Mansfield Agitation Inventory (CMAI) Neuro-psychiatric Inventory-Nursing Home Version (NPI-NH)

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

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

Summary Monitoring Efficacy & Adverse Consequences:
Track progress towards therapeutic goals Detect adverse consequences Parameters – resident’s condition, pharmacological properties & risks, individualized therapeutic goals, clinically significant adverse consequences Monitoring Tools and Methods job aid

Dose (Including Duplicate Therapy)

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

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

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

Drugs Don’t Have Doses, People Do!

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

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

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

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

Duration

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

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

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

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

Tapering of Medication Dose/Gradual Dose Reduction (GDR) for Antipsychotic Medications

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

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

Non-Pharmacologic Behavioral Intervention

Factors to Consider Coexisting medication regimen
Underlying causes of symptoms Individual risk factors Pharmacological characteristics

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

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

Pharmacologic Behavior Management
Often over-rated, over-utilized, and lacking adequate documentation.

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

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

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

Antipsychotic indication & GDR Contraindications
Behavioral symptoms related to dementia 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 increase distressed behavior.

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

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.

Antipsychotics BW 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.

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

Tapering 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)

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

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

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

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

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.

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

Hypnotics The 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.

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

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

Psychopharmacological Medications The 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.

Tapering and GDR When 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 review During review of total care plan and renewing of orders During quarterly MDS review We’ve already discussed monitoring of psychopharmacological and sedative-hypnotic medications and the expectation for a quarterly review of necessity and dose.

Tapering/GDR Opportunities for evaluation of medication, in regards to duration/dose: Consultant Pharmacist’s MRR Physician’s visit or signing of orders During quarterly MDS review What 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

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

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

Prevention, Identification & Response to Adverse Consequences

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

ADRs Increase With Number of Medications

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

Adverse Consequences Delirium
Common medication-related adverse consequence Individuals who have dementia may be at greater risk for delirium Delirium is associated with higher morbidity and mortality Message: 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.

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

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

Question According to the investigative protocol guidance, which of the following signs or symptoms may be associated with medications: Dehydration Constipation Bruising All of the above

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

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

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

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

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

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

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

Analgesics 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.

Antibiotics All 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).

Anticoagulants, Anticonvulsants, Antidepressants
Warfarin INRs; interactions Anticonvulsants 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.

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

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

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

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

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

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

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

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

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

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

Antipsychotic Dose Thresholds in Dementing Illnesses
Chlorpromazine 75mg Fluphenazine 4mg Haloperidol 2mg Loxapine 10mg Molindone 10mg Perphenazine 8mg Thioridazine 75mg Thiothixene 7mg Trifluoperazine 8mg Aripiprazole 10mg Clozapine 50mg Olanzapine 7.5mg Quetiapine 150mg Risperidone 2mg

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

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

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

Anxiolytics: Dosage Thresholds
Flurazepam mg Chlodiazepoxide 20mg Clorazepate mg Diazepam mg Cloazepam mg Quazepam mg Esazolam mg Alprazolam 0.75mg Oxazepam mg Lorazepam mg

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

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

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

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

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

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

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

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

Gastrointestinal medications
Prochlorperazine, promethazine Caution in Parkinson’s, narrow-angle glaucoma, BPH, seizure disorder. Sedation, dizziness, postural hypotension, NMS Anticholinergic effects Extrapyramidal symptoms and T.D. Arrhythmias Trimethobenzamide Relatively ineffective; EPSE, lethargy, sedation, confusion

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

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

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

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

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

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

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

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

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

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

Daily Dose Thresholds for Sedative/Hypnotics
Chloral hydrate mg Diphenhydramine 25mg Estazolam 0.5mg Eszopiclone 1mg Flurazepam 15mg Hydroxyzine 50mg Lorazepam 1mg Oxazepam 15mg Quazepam 7.5mg Ramelteon 8mg Temazepam 15mg Triazolam mg Zaleplon 5mg Zolpidem IR 5mg Zolpidem CR mg

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

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

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

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

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

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

Examples of medications with anticholinergic properties Antiparkinson (amantadine, benztropine, biperiden, trihexyphenidyl) Muscle Relaxants (cyclobenzaprine, dantrolene, orphenadrine) Antipsychotic (chlorpromazine, clozapine, olanzapine, thioridazine) Phenothiazine (prochlorperazine, promethazine) Urinary Incontinence (oxybutynin, probanthaline, solifenacin, tolterodine, trospium)

78 y.o. F. nursing home resident
Meds: Furosemide 20mg b.i.d. Reglan 10mg b.i.d. Calcium 500mg t.i.d. Senna-S b.i.d. Risperdal 0.5mg b.i.d. Metamucil 1 tsp b.i.d. Hydroxyzine 25mg p.r.n. MOM 15 ml q.d. Cogentin 1mg b.i.d. Naproxen 375mg b.i.d. Medical Problems: Dementia Constipation Dermatitis Osteoporosis Edema Parkinsonism Reflux esophagitis DJD

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

F425,428, 431-What’s Changed? Only the Guidance has changed.
Increased information on what is pharmaceutical services. Increased information about MRR.

F428 Medication Regimen Review
Interpretive Guidelines

Intent The 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 medications Identification and reporting of irregularities Action taken in response to irregularities Message: 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.

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

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

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

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

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

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

MRR Considerations MRR considers factors, such as:
Has physician/staff documented objective findings, diagnoses, symptoms to support indication? Has physician/staff identified and acted upon, or should they be notified about, 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?

MRR Considerations Has physician/staff documented progress towards or maintenance of the goal(s) for medications therapy? Has physician/staff obtained and acted upon lab results, diagnostic studies, or other measurements? Do med errors exist or do circumstances exist that make errors likely to occur?

MRR Considerations Has 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 gain Behavioral changes, unusual behavior patterns Bowel function changes Confusion, cognitive decline, worsening of dementia Dehydration, fluid/electrolyte imbalance Depression, mood disturbance

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

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

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

Response to Findings Physician either:
Accepts recommendation and acts, OR Rejects the recommendation and provides a brief explanation, such as in a dated progress note “It is not acceptable for a physician to document only that he/she disagrees with the report without providing some basis for disagreeing.” For those direct care issues that do not require physician intervention, DON or designated nurse can address and document action taken

Lack of Action or Rejection
What about when MD does not act upon or rejects MRR report/recommendations and there is the potential for serious harm? Facility and CP should contact Medical Director, OR When attending and Medical Director are same, follow established facility procedure to resolve the situation No specific timeframe provided for when a report that is not acted upon officially becomes delinquent or “not acted upon”

Lack of Action or Rejection
What about continuing to document an issue that the physician has disregarded or rejected? “Pharmacist does not need to document a continuing irregularity each month if it’s deemed to be clinically insignificant or there is evidence of valid clinical reason for rejection” “In these situations, pharmacist need only reconsider annually whether to report again or make new recommendation.”

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

Medication-Related Problems
A Medication-Related Problem (MRP) is: (NOTE HOW SIMILAR THESE ARE TO THE UNNECESSARY MED ‘CATEGORIES’ IN F-TAG 329) Use of a medication without adequate indication for use Use of a medication without identifiable evidence that safer alternatives or more clinically appropriate medications have been considered

Medication-Related Problems (cont.)
Use of an appropriate medication that is not reaching treatment goals for reasons such as timing or techniques of administration, dosing intervals, etc. Use of a medication in an excessive dose (including duplicate therapy) or for excessive duration Presence of an adverse consequence associated with medication(s)

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

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

Medication Errors A 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:

Irregularities An irregularity is:
“Any event that is inconsistent with usual, proper, accepted, or right approaches to providing pharmaceutical services (as defined by F425), or that impedes or interferes with achieving the intended outcomes of those services.”

F428 - MRR Given those definitions, it is important to note that the document also states: “This guidance is not intended to imply that all adverse consequences related to medications are preventable, but rather to specify that a SYSTEM exists to assure that medication usage is evaluated on an ongoing basis…”

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

Where to Conduct the Review
Generally within facility because important info may be attainable only by talking to staff, reviewing “paper” chart, observing/speaking with resident BUT new technology (electronic health records) may permit the pharmacist to conduct some components of the review outside of the facility

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

Location 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 available Find balance between: Encouraging/facilitating other healthcare professionals to utilize Allowing facilities flexibility in determining a consistent location that suits their needs

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

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

F425 Pharmaceutical Services

Definitions 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; and The 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.

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

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

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

Pharmacist Services Consultant 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 pharmacies Infusion provider Hospice Prescription Drug Plan (PDP)

Pharmacist 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

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

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

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

Pharmaceutical Services
Acquisition Receiving & Dispensing Administering Disposition Labeling Storage Controlled Drugs

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

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

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

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

F431 Storage, Labeling, Controlled Medications

Intent The facility, in coordination with the pharmacist, provides:
Safe and secure storage and handling of all medication Accurate labeling to facilitate safe administration A system of records enabling reconciliation and accounting of controlled medications Identification of loss or diversion of controlled medications minimizing the time between actual loss and the detection of the extent of loss Message: The safe and secure storage and handling of medications includes: Accurate labeling Storage of medications in accordance with the manufacturers recommendations such as proper temperature controls Secure storage including limiting access to the medications and safe disposition, of medications; and A system in place to account for and to minimize loss or diversion of all controlled medications and other medications subject to abuse.

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

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

For OTCs in bulk containers (in states that permit), label contains: Original manufacturer’s OR pharmacy-applied label indicating: Medication name Strength Quantity Accessory instructions Lot number Expiration date, when applicable If resident-specific supply of OTC, label contains above plus resident’s name

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

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

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

Record of RECEIPT of ALL controlled medications with sufficient to allow reconciliation, specifying: Name and strength of medication Quantity Date received Resident’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., MAR Proof-of-use sheets Declining inventory sheets Emergency Kits…. Don’t forget about controlled medications located in the emergency supply

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

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

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