MEDICATIONS

IN  THE  NURSING  HOME

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       Understanding medications in the nursing home is important for concerned family members. Even though the following review of prescribing medications in the nursing home is long and sometimes technical, it should be well worth the time and effort to read.  The invisible workings of medications may expose the resident to far more risk than any other aspect of nursing home care.  Historically, family members have played an important part in better drug therapy management by learning all they can about the medications their loved one is receiving and speaking out when a problem is apparent.


                                                      

PAGE CONTENTS

              ∆  Medications in the nursing home.

              ∆  Medications management.

              ∆  Definitions related to medications.

              ∆  Resident’s choice.

              ∆  Medications and advanced directives.

              ∆  Indications for medications.

              ∆  Medications dose.

              ∆  Duration of medication therapy.

              ∆  Replacing medication treatments.

              ∆  Medications safety.

              ∆  Medications of concern.

              ∆  Monitoring for results and adverse

                    consequences.

              ∆  Adverse consequences.

              ∆  Symptoms & conditions possibly

                    associated with drugs.

              ∆  Tapering medication dosage.

              ∆  Unnecessary drugs.



  ∆  Medications in the nursing home.

    Medications are an integral part of the care provided to residents of nursing facilities.  They are administered to achieve various outcomes such as curing an illness, diagnosing a disease or condition, arresting or slowing a disease process, reducing or eliminating symptoms, or preventing a disease or symptom.


   Many drugs have played a positive role in limiting or solving health problems but medications are not a universal solution.  The positive and successful use of medication to care for residents, promote maintenance of or enhance the quality of life, and attain or maintain the highest practicable physical, mental, and psychosocial well being of each resident is complicated considering there may be adverse results from the same medication.  Even when a medication is not indicated for a condition, there is a strong urge to try something and drugs offer a simple and visible attempt to gain improvement.


    A study of 33,301 nursing facility residents found that an average of 6.7 medications were ordered per resident, with 27 percent of residents taking nine or more medications. Analysis of antipsychotic use by 693,000 Medicare nursing home residents revealed that 28.5 percent of the doses received were excessive and 32.2 percent lacked appropriate indications for use.


    Proper medication selection may help stabilize or improve a resident’s care outcome, quality of life, and functional capacity. Any medication, combination of medications, the use of a medication without adequate indications, in excessive dose, for excessive duration, or use without adequate monitoring may increase the risk of a broad range of adverse consequences such as medication interactions, depression, confusion, immobility, falls, and related hip fractures.


  ∆  Medications management.

    Medication management is an important part of the care process.  The process includes recognition or identification of the problem or need, an assessment, an identified diagnosis or cause, developing a management or treatment plan, monitoring the condition and treatment response, and revising interventions as warranted.


   The attending physician plays a key leadership role in medication management by developing, monitoring, and modifying the medication regimen in conjunction with residents, their personal representative, other professionals, and the direct care team.


  When selecting medications and non-pharmacological interventions, members of the interdisciplinary care team participate in the process to identify, assess, address, advocate for, monitor, and communicate the resident’s needs and changes in condition.


    The facility’s medication management process should support and promote:

  1. Selection of medications based on assessing relative benefits and risks to the individual resident;

  2. Evaluation of a resident’s signs and symptoms to identify the underlying cause or causes, including adverse consequences of medications;

  3. Selection and use of medications in doses and for the duration appropriate to each resident’s clinical conditions, age, and underlying causes of symptoms;

  4. The use of non-pharmacological intervention to minimize the need for medications, permit use of the lowest possible dose, or allow medications to be discontinued; and

• The monitoring of medications for efficacy and clinically significant adverse consequences.


  ∆  Definitions related to medications.

    The following definitions may help to clarify terminology related to medications and the evaluation and treatment of residents. Although the regulatory language refers to “drugs,” this document will generally refer to both drugs and medications except in those situations where the term “drug” has become part of an established pharmaceutical term such as adverse drug event, and adverse drug reaction or consequence.


  1. Adverse consequence - 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 such as medication-medication, medication-food, and medication-disease.


  1. Adverse drug reaction (ADR) - ADR is a form of adverse consequences. It may be either a secondary effect of a medication that is usually undesirable and different from the therapeutic effect of the medication or any response to a medication that is noxious and unintended and occurs in doses for prophylaxis, diagnosis, or treatment.  The term “side effect” is often used interchangeably
    with ADR; however, side effects are but one of five ADR categories, the others being hypersensitivity, idiosyncratic response, toxic reactions, and adverse medication interactions. A side effect is an expected, well-known reaction that occurs with a predictable frequency and may or may not constitute an adverse consequence.


  1. Anticholinergic side effect - An effect of a medication that opposes or inhibits the activity of the parasympathetic nervous system to the point of causing symptoms such as dry mouth, blurred vision, tachycardia, urinary retention, constipation, confusion, delirium, or hallucinations.


  1. 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.


  1. Clinically significant - 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 by negatively exacerbating, causing, or contributing to a symptom, illness, or decline in status.


  1. Distressed behavior - 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.


  1. Dose - The total amount/strength/concentration of a medication given at one time or over a period of time. The individual dose is the amount/strength/concentration received at each administration. The amount received over a 24-hour period may be referred to as the daily dose.


  1. Excessive Dose -  The total amount of any medication, including duplicate therapy, given at one time or over a period of time that is greater than the amount recommended by the manufacturer’s label, package insert, current standards of practice for a resident’s age and condition, or clinical studies or evidence-based review articles that are published in medical and/or pharmacy journals and that lacks evidence of:

    * A review for the continued necessity of the dose;

    * Attempts at, or consideration of the possibility of, tapering a medication; and

    * A documented clinical rationale for the benefit of, or necessity for, the dose or for the use of

       multiple medications from the same pharmacological class.


  1. Duplicate therapy - Multiple medications of the same pharmacological class/category or any medication therapy that substantially duplicates a particular effect of another medication that the individual is taking.


  1. Excessive duration - The medication is administered beyond the manufacturer’s recommended time frames or facility-established stop order policies, beyond the length of time advised by current standards of practice, clinical practice guidelines, clinical studies or evidence-based review articles, and/or without either evidence of additional therapeutic benefit for the resident or clinical evidence that would warrant the continued use of the medication.


  1. Extrapyramidal symptoms (EPS) - Neurological side effects that can occur at any time from the first few days of treatment to years later. EPS includes various syndromes such as:

  o Akathisia - A distressing feeling of internal restlessness that may appear as constant motion, the inability to sit still, fidgeting, pacing, or rocking.

o Medication-induced Parkinsonism - A syndrome of Parkinson-like symptoms including tremors, shuffling gait, slowness of movement, expressionless face, drooling, postural unsteadiness and rigidity of muscles in the limbs, neck and trunk.

   o Dystonia - An acute, painful, spastic contraction of muscle groups, commonly the neck, eyes and trunk, that often occurs soon after initiating treatment and is more common in younger individuals.


  1. Gradual dose reduction (GDR) - 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.


  1. Indications for use - 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.


  1. Medication interaction - The impact of another substance, such as another medication, nutritional supplement including herbal products, food, or substances used in diagnostic studies, upon a medication. The interactions may alter absorption, distribution, metabolism, or elimination. These interactions may decrease the effectiveness of the medication or increase the potential for adverse consequences.


  1. Medication regimen review (MRR) - A thorough evaluation of the medication regimen by a pharmacist, with the goal of promoting positive outcomes and minimizing adverse consequences associated with medication. The review includes preventing, identifying, reporting, and resolving medication-related problems, medication errors, or other irregularities in collaboration with other members of the interdisciplinary care team.


  1. Monitoring - The ongoing collection and analysis of information such as observations and diagnostic test results and comparison to baseline data in order to:

   o  Ascertain the individual’s response to treatment and care, including progress or lack of progress

        toward a therapeutic goal;

   o Detect any complications or adverse consequences of the condition or of the treatments; and

   o Support decisions about modifying, discontinuing, or continuing any interventions.


  1. Neuroleptic malignant syndrome (NMS) - A syndrome related to the use of medications, mainly antipsychotics, that typically presents with a sudden onset of diffuse muscle rigidity, high fever, possible blood pressure problems, tremor, and notable cognitive dysfunction. It is potentially fatal if not treated immediately, including stopping the offending medications.


  1. Non-pharmacological interventions - Approaches to care that do not involve medications, generally directed towards stabilizing or improving a resident’s mental, physical or psychosocial well-being.


  1. Psychopharmacological medication - Any medication used for managing behavior, stabilizing mood, or treating psychiatric disorders.


  1. Serotonin syndrome - A potentially serious clinical condition resulting from overstimulation of serotonin receptors. Symptoms may include restlessness, hallucinations, confusion, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea.


  1. Tardive dyskinesia - Abnormal, recurrent, involuntary movements that may be irreversible and typically present as lateral movements of the tongue or jaw, tongue thrusting, chewing, frequent blinking, brow arching, grimacing, and lip smacking, although the trunk or other parts of the body may also be affected.


  ∆  Resident’s choice.

   A resident and their personal representative has the right to be informed about the resident’s condition; treatment options, relative risks and benefits of treatment, required monitoring, expected outcomes of the treatment; and has the right to refuse care and treatment including medications. If a resident refuses treatment, the facility staff and physician should inform the resident about the risks related to the refusal, discuss appropriate alternatives such as offering the medication at another time or in another dosage form, or offer an alternative medication or non-pharmacological approach, if available.


  ∆  Medications and advanced directives.

    A resident may have written or verbal directions related to treatment choices or a decision has been made by the resident’s surrogate or representative in accordance with state law. An advance directive is a means for the resident to communicate his or her wishes, which may include withdrawing or withholding medications. Whether or not a resident has an advanced directive, the facility is responsible for giving treatment, support, and other care that is consistent with the resident’s condition and care instructions.


    Choosing not to be resuscitated in a Do Not Resuscitate (DNR) order indicates that the resident should not be resuscitated if respirations and/or cardiac function cease. A DNR order by itself does not indicate that the resident has declined other appropriate treatment and services such as medications.


  ∆  Indications for medications.

    An evaluation of the resident helps to identify his or her needs, presence of more chronic conditions, and prognosis to determine factors, including medications and new or worsening medical conditions, that are affecting signs, symptoms, and test results. This evaluation process is important when making initial medication or other intervention selections and when deciding whether to modify or discontinue a current medication intervention.


    The evaluation also clarifies:

  1. Whether other causes for the symptoms, including behavioral distress that could mimic a psychiatric disorder, have been ruled out;

  2. Whether the signs, symptoms, or related causes are persistent or clinically significant enough by causing functional decline to warrant the initiation or continuation of medication therapy;

  3. Whether non-pharmacological interventions are considered;

  4. Whether a particular medication is clinically indicated to manage the symptom or condition; and

  5. Whether the intended or actual benefit is sufficient to justify the potential risks or adverse consequences associated with the selected medication, dose, and duration.


    Specific considerations should be given to the following circumstances:

  1. Admission or Readmission – Some residents may be admitted on medications for an undocumented chronic condition or without a clear indication as to why a medication was begun or should be continued. It is expected that the attending physician, pharmacist, and staff subsequently determine if continuing the medication is justified by evaluating the resident’s clinical condition, risks, existing medication regimen, and related factors. If the indications for continuing the medication are unclear, or if the resident’s symptoms could represent a clinically significant adverse consequence, additional consideration of the rationale for the medication is warranted.


  1. Multiple prescribers – Regardless of who the prescribers are, the continuation of a medication needs to be evaluated to determine if the medication is still warranted in the context of the resident’s other medications and comorbidities. Medications prescribed by a specialist or begun in another care setting, such as the hospital, need to have a clinically pertinent documented rationale.


  1. New medication order as an emergency measure – When a resident is experiencing an acute medical problem or psychiatric emergency, that is the resident’s behavior poses an immediate risk to the resident or others, medications may be required. In these situations, it is important to identify and address the underlying causes of the problem or symptoms. Once the acute phase has stabilized, the staff and prescriber consider whether medications are still relevant. Subsequently, the medication is reduced or discontinued as soon as possible or the clinical rationale for continuing the medication is documented.


  1. Psychiatric disorders or distressed behavior – As with all symptoms, it is important to seek the

   underlying cause of distressed behavior, either before or while treating the symptom.


  ∆  Medications dose.

  A prescriber orders medication based on a variety of factors including the resident’s diagnoses, signs and symptoms, current condition, age, coexisting medication regimen, review of lab and other test results, input from the interdisciplinary team about the resident, the type of medication, and therapeutic goals being considered or used.


    Factors influencing the appropriateness of any dose include the resident’s clinical response, possible adverse consequences, and other resident and medication-related variables. Often, lab test results such as serum medication concentrations are only a rough guide to dosing. Significant adverse consequences can occur even when the concentration is within the therapeutic range. Serum concentrations alone may not necessarily indicate a need for dose adjustments, but may warrant further evaluation of a dose or the medication regimen.


    The route of administration influences a medication’s absorption and ultimately the dose received. Examples of factors that can affect the absorption of medications delivered by transdermal patches include skin temperature and moisture, and the integrity of the patch. Similarly, the flow rate of intravenous solutions affects the amount received at a given time.


    Duplicate therapy is generally not indicated unless current clinical standards of practice and documented clinical rationale confirm the benefits of multiple medications from the same class or with similar therapeutic effects.  Documentation is necessary to clarify the rationale for and benefits of duplicate therapy and the approach to monitoring for benefits and adverse consequences.


  ∆  Duration of medication therapy.

    Many conditions require treatment for extended periods, while others such as acute conditions of cough and cold symptoms, upper respiratory condition, nausea and/or vomiting, acute pain, psychiatric or behavioral symptoms may resolve and no longer require medication therapy.


    Periodic re-evaluation of the medication regimen is necessary to determine whether prolonged or indefinite use of a medication is indicated. The clinical rationale for continued use of a medication may have been demonstrated in the clinical record, or the staff and prescriber may present pertinent clinical reasons for the duration of use.


  ∆  Replacing medication treatments.

    While assuring that only those medications required to treat the resident’s assessed condition are being used, reducing the need for and maximizing the effectiveness of medications are serious considerations for all residents.  An important part of all medication management, including antipsychotics, is for the interdisciplinary care planning team to consider non-medication approaches. A well informed facility staff and other medical providers can first apply non-pharmacological approaches to resident conditions before and/or in conjunction with, the use of medications.  Such an approach may minimize the need for medications or reduce the dose and duration of those medications.


    Examples of non-pharmacological treatments may include:

  1. *Increasing the amount of resident exercise and intake of liquids and dietary fiber in conjunction with an individualized bowel regimen to prevent or reduce constipation and the use of medications such as laxatives and stool softeners;

  2. *Identifying, addressing, and eliminating or reducing underlying causes of distressed behavior such as boredom and pain;

  3. *Using sleep hygiene techniques and individualized sleep routines.

  4. *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;

  5. *Individualizing toileting schedules to prevent incontinence and avoid the use of incontinence medications that may have significant adverse consequences such as inhibiting the transmission of nerve impulses;

* Developing interventions that are specific to resident’s interests, abilities, strengths and needs, such

   as simplifying or segmenting tasks for a resident who has trouble following complex directions;

  1. *Using massage and hot, warm, or cold compresses to address a resident’s pain or discomfort; or

  2. *Enhancing the taste and presentation of food, assisting the resident to eat, addressing food

   preferences, and increasing finger foods and snacks for an individual with dementia to improve

   appetite and avoid the unnecessary use of medications intended to stimulate appetite.


    The indications for initiating, withdrawing, or withholding medication as well as the use of non-pharmacological approaches are determined by assessing the resident’s underlying condition, current signs and symptoms, and preferences and goals for treatment. This includes the identification of the underlying cause, where possible, because a diagnosis alone may not warrant treatment with medication.


  Medication safety.

    Staff and practitioner access to current medication references and pertinent clinical protocols helps to promote safe administration and monitoring of medications. One of the existing mechanisms to warn prescribers about risks associated with medications is the Food and Drug Administration (FDA) requirement that manufacturers include within the medication labeling warnings about adverse reactions and potential safety hazards identified both before and after approval of a medication, and what to do if they occur.


   Manufacturers are required to update labels to warn about newly identified safety hazard, regardless of whether causation has been proven and whether the medication is prescribed for a disease or condition that is not included in the “Indications and Usage” section of the labeling, the “off-label” or a use not approved for the product. The FDA may require manufacturers to place statements about serious problems in a prominently displayed box, often called boxed or “black box” warnings, which indicates a need to closely evaluate and monitor the potential benefits and risks of that medication.


    The facility’s consulting pharmacist is a valuable source of information about medications. Listings or descriptions of most significant risks, recommended doses, medication interactions, cautions, etc. can be found in widely available, standard references, and computer software and systems providing up-to-date information.


    Clinical standards of practice and clinical guidelines established by professional groups are useful to guide the nursing home care staff. Available clinical resources recognized by Medicare/Medicaid provide understanding for the overall treatment and management of medical problems, symptoms and medication consequences and precautions.  Although these guidelines generally emphasize the older adult resident, adverse consequences can occur in anyone at any age; therefore, these requirements apply to residents of all ages.


    Naturally occurring factors including physiological changes accompanying the aging process, multiple chronic diseases, and certain medical conditions may affect the absorption, distribution, metabolism or elimination of medications from the body and may also increase an individual’s risk of adverse consequences.


    Orders  from multiple prescribers can increase the resident’s chances of receiving unnecessary medications. Many residents receive orders for medications from several practitioners, for example, attending and on-call physicians, consultants, and nurse practitioner. It is important that the facility clearly identify who is responsible for prescribing and identifying the indications for use of medication, for providing and administering the medication, 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, other care providers, or special service suppliers such as hospice or dialysis services.



    The sources of standards and practices mention above can be found in Appendix PP, 483.25(l) Unnecessary Drugs at:

http://www.cms.gov/manuals/Downloads/som107ap_pp_guidelines_ltcf.pdf


      The Food and Drug Administration has a website offering medical product safety information at:     www.fda.gov/medwatch/safety.htm


   The webpage Medication Errors in the Nursing Home can be accessed by clicking HERE.



  ∆  Medications of concern.

    A significant number of medications have been identified as having the potential to cause clinically adverse consequences, have limited indications for use, require specific monitoring, and which warrant careful consideration of relative risk and benefit for use in the nursing home.


    The medications reference Table I which lists medications of concern is available below by web link to research the medications prescribed for your family member.  This table is based on reviews of a variety of pharmaceutical references. It does not include all categories of medications or all medications within a category, and does not address all issues or considerations related to medication use, such as dosages. Medications other than those listed in this table may also present significant issues related to indications, dosage, duration, monitoring, or potential for clinically significant adverse consequences.  Inclusion of a medication in this table does not imply that it is contraindicated for every resident.


    Since medication issues continue to evolve and new medications are being approved regularly, it is important to refer to a current authoritative source for detailed medication information such as indications and precautions, dosage, monitoring, or adverse consequences.


    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.


     

    The webpage Medications of Concern in the Nursing Home with more information on problems from medications can be accessed by clicking HERE;


    The reference document, Table I - Medication Issues of Particular Relevance listing medications under generic names with issues and concerns related to each drug is available at:       www.ncdhhs.gov/dhsr/nhlcs/pdf/phar_medication.pdf.



  ∆  Monitoring for results and adverse consequences.

   The key objectives for monitoring the use of medications are to track progress towards the therapeutic goal(s) and to detect the emergence or presence of any adverse consequences.


  Monitoring parameters are based on the resident’s condition, the pharmacologic properties of the medication being used and its associated risks, individualized therapeutic goals, and the potential for clinically significant adverse consequences.


    Adverse consequences related to medications are common enough to warrant serious attention and close monitoring. For example, a study reported that 338 (42%) of 815 adverse drug events were judged preventable, and that common omissions included inadequate monitoring and either lack of response or a delayed response to signs, symptoms, or laboratory evidence of medication toxicity.


    Monitoring of the resident’s response to any medication is essential to evaluate the ongoing benefits as well as risks of various medications. It is important, for example, to monitor the effectiveness of medications used to address behavioral symptoms by behavioral monitoring or to treat hypertension by periodic pulse and blood pressure checks.


    Monitoring for adverse consequences involves ongoing vigilance and may periodically involve objective evaluation such as assessing vital signs which may be indicated if a medication is known to affect blood pressure, pulse rate and rhythm, or temperature.


    Additional examples of circumstances that may indicate a need to modify the monitoring include: changes in manufacturer’s specifications, FDA warnings, pertinent clinical practice guidelines, or other literature about how and what to monitor.


  ∆  Adverse consequences

    Any medication or combination of medications such as interactions between multiple medications with sedative or anticholinergic effects can cause adverse consequences. Some adverse consequences occur quickly or abruptly, while others are more insidious and develop over time. Adverse consequences may become evident at any time after the medication is initiated, that is when there is a change in dose or after another medication has been added.


    When reviewing medications used for a resident, it is important to be aware of the medication’s recognized safety profile, tolerability, dosing, and potential medication interactions. Although a resident may have an unanticipated reaction to a medication that is not always preventable, many adverse drug reactions can be anticipated, minimized, or prevented.


    Published studies have sought to identify the frequency, severity, and preventability of adverse consequences. Neuropsychiatric, hemorrhagic, gastrointestinal, renal/electrolyte abnormalities and metabolic/endocrine complications were the most common overall and preventable adverse consequences identified in two nursing home studies.


   Specifically, a study of 18 community-based nursing homes reported that approximately 50 percent (276 of 546) of all the adverse consequences—and 72 percent of those characterized as fatal, life-threatening, or serious—were considered preventable.  A second study of two academic-based nursing homes reported that inadequate monitoring, failure to act on the monitoring, and errors in ordering, including wrong dose, wrong medication, and medication-medication interactions were the most frequent causes for the preventable adverse consequences.  The risk for adverse consequences increases with both the number of medications being taken regularly and with medications from specific pharmacological classes, such as anticoagulants, diuretics, antipsychotics, anti-infectives, and anticonvulsants. Adverse consequences can range from minimal harm to functional decline, hospitalization, permanent injury, and death.



        A reference table of Common Medication-Medication Interactions in Long Term Care is available at:

www.health.state.mn.us/divs/fpc/cww/D04_Transmittal22ExcerptCommonMedInter.pdf



  Symptoms & conditions possibly associated with drugs.

  Problems with medications can take many forms and may not readily be seen as a consequence of drug therapy. It is important to consider the possibility that the changes in condition may be medication induced or influenced.


    If the resident has been transferred to acute care and/or has, in the last three months, experienced a change in condition or currently has signs and symptoms such as the following, there is the possibility of adverse medication consequences.

•    Anorexia and/or unplanned weight loss, or weight gain.

•    Behavioral changes, unusual behavior patterns including increased distressed behavior.

•    Bleeding or bruising, spontaneous or unexplained.

•    Bowel dysfunction including diarrhea, constipation and impaction.

•    Dehydration, fluid/electrolyte imbalance.

•    Depression, mood disturbance.

•    Dysphagia, swallowing difficulty.

•    Excessive sedation, insomnia, or sleep disturbance.

•    Falls, dizziness, or evidence of impaired coordination.

•    Gastrointestinal bleeding.

•    Headaches, muscle pain, generalized or nonspecific aching or pain.

  1.    Mental status changes such as new or worsening confusion, new cognitive decline, or worsening

      of dementia including delirium.

•    Rash, pruritus.

•    Respiratory difficulty or changes.

•    Seizure activity.

  1.    Urinary retention or incontinence.


    If observations or medical records indicate symptoms or changes in condition that may be related to drugs covered in Tables I and II above, the facility should considered medications as a potential cause of the change or symptom.


  ∆  Tapering medication dosage.

   The purpose of tapering or gradual dose reduction (GDR) of a medication is to find an optimal dose or to determine whether continued use of the medication is benefiting the resident.  The requirements underlying this guidance emphasize the importance of seeking an appropriate dose and duration for each medication and minimizing the risk of adverse consequences.


    Tapering may be indicated when the resident’s clinical condition has improved or stabilized, the underlying causes of the original target symptoms have resolved, and/or non-pharmacological interventions, including behavioral interventions, have been effective in reducing the symptoms.


    Sometimes, the decision to continue a medication is clear; for example, someone with a history of multiple episodes of depression or recurrent seizures may need an antidepressant or anticonvulsant medication indefinitely. Often the only way to know whether a medication is needed indefinitely and whether the dose remains appropriate is to try reducing the dose and to monitor the resident closely for improvement, stabilization, or decline.


    The time frames and duration of attempts to taper any medication depend on factors including the coexisting medication regimen, the underlying causes of symptoms, individual risk factors, and pharmacologic characteristics of the medications. Some medications such as antidepressants, sedative/hypnotics, opioids require more gradual tapering so as to minimize or prevent withdrawal symptoms or other adverse consequences.


    If the resident’s condition has not responded to treatment or has declined despite treatment, it is important to evaluate both the medication and the dose to determine whether the medication should be discontinued or the dosing should be altered, whether or not the facility has implemented GDR as required, or tapering.


  A chart of GDR/Tapering Considerations is available at:

http://www.ncdhhs.gov/dhsr/nhlcs/pdf/phar_tapering.pdf


 

  ∆  Unnecessary Drugs.

    Medicare and Medicaid regulations address the use of drugs or medications to treat clearly identified medical conditions in the nursing home.  Possibly the most important concern is the overuse or administration of unnecessary drugs.  The problem is addressed by regulation §483.25(l) Unnecessary Drugs as follows.


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 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.


2. Antipsychotic Drugs: Based on a comprehensive assessment of a resident, the facility must ensure that:

   (i) Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and

    (ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.


    The intent of this requirement is that each resident’s entire drug/medication regimen be managed and monitored to achieve the following goals:

  1. The medication regimen helps promote or maintain the resident’s highest practicable mental, physical, and psychosocial well-being, as identified by the resident or personal representative in collaboration with the attending physician and facility staff;

  2. Each resident receives only those medications, in doses and for the duration clinically indicated to treat the resident’s assessed conditions;

  3. Non-pharmacological interventions such as behavioral interventions are considered and used when indicated, instead of, or in addition to, medication;

  4. Clinically significant adverse consequences are minimized; and

  5. The potential contribution of the medication regimen to an unanticipated decline or newly emerging or worsening symptom is recognized and evaluated, and the regimen is modified when appropriate.




The full text of Appendix PP, §483.25(l) Unnecessary Drugs is available at:

www.cms.gov/manuals/Downloads/som107ap_pp_guidelines_ltcf.pdf


    End Note: The majority of Medications in the Nursing Home, is edited material from Medicare/Medicaid regulation Appendix PP, §483.25(l) Unnecessary Drugs. The order of presentation for some material has been changed, information not supporting an understanding of prescribing medications in the nursing home was deleted, and wording and organizational changes were made to create an easier to read document.



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