The OIG has also identified in its 2008 Supplemental Compliance Guidance for Nursing Facilities the risk area of medication management. The OIG’s focus on this area of care is based almost exclusively on existing OBRA federal regulations and CMS guidance on medication management. Therefore, facility staff and compliance team members should be intimately familiar with the following information from those regulations and CMS guidance governing medication management:
- F329 § 483.25(1) Unnecessary Drugs:
- General. Each resident’s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used:
- In excessive dose (including duplicate therapy); or
- For excessive duration; or
- Without an adequate monitoring; or
- Without adequate indications for its use; or
- In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or
- Any combinations of the reasons above.
- The intent of § 483.25(l):
- The medication regimen helps promote or maintain the resident’s highest practicable mental, physical, and psychosocial well-being, as identified by the resident and/or representative(s) in collaboration with the attending physician and facility staff;
- Each resident receives only those medication, in doses and for the duration clinically indicated to treat the resident’s assessed condition(s);
- Non-pharmacological interventions (such as behavioral interventions) are considered and used when indicated, instead of, or in addition to, medication;
- Clinically significant adverse consequences are minimized; and
- 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.
An important definition relating to medication management includes:
- “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). Adverse drug reaction (ADR) is a form of adverse consequences. 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 interaction. A side effect is of expected, well-known reaction that occurs with a predictable frequency or may not constitute an adverse consequence.
In addition to the federal OBRA regulations on medication management, CMS has addressed this risk area in its State Operations Manual (“SOM”), as follows:
- Proper medical selection in prescribing (including dose, duration, and type of medication(s) may help stabilize or improve a resident’s outcome, quality of life and functional capacity. Any medication or combination of medication – or the use of a medication without adequate indications, in excessive dose, for an excessive duration, or 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.
Under the regulations medication management includes consideration of:
- Indications for use of medication (including initiation or continued use of antipsychotic medication);
- Monitoring for ethicacy and adverse consequences;
- Dose (including duplicate therapy);
- Tapering of a medication dose/gradual dose reduction for antipsychotic medication; and
- Prevention, identification, and response to adverse consequences.
There are circumstances that warrant evaluation of resident and his or her medications which include the following:
- Admission or re-admission;
- A clinically significant change in condition/status;
- A new, persistent, or recurrent clinically significant symptom or problem;
- A worsening of an existing problem or condition;
- An unexplained decline in function or cognition;
- A new medication order or renewal of orders; and
- An irregularity identified in the pharmacist’s monthly medication regimen review.
Monitoring medications is a key element of compliance, including:
- Monitoring of the resident’s response to any medication(s) 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 (e.g., behavioral monitoring) or to treat hypertension (e.g., periodic pulse and blood pressure). Monitoring for adverse consequences involves ongoing vigilance and may periodically involve objective evaluation (e.g., assessing vital signs may be indicated if a medication is known to affect blood pressure, pulse rate and rhythm, or temperature). Using quantitative and qualitative monitoring parameters facilitates consistent and objective collection of information by the facility.
As part monitoring, the SOM also focuses on re-evaluating and updating monitoring approaches, including:
- Modification may be necessary when the resident experiences changes, such as:
- Acute onset of signs or symptoms or worsening of chronic disease;
- Decline in function or cognition;
- Addition or discontinuation of medications and/or non-pharmacological interventions;
- Addition or discontinuation of care and services such as enteral feedings; or
- Significant changes in diet that may affect medication absorption or effectiveness of increase adverse consequences.
- Additional examples of circumstances that may indicate a need to modify the monitoring include:
- changes in manufacture’s specifications,
- FDA warnings, or
- pertinent clinical practice guidelines, or other literature about how and what to monitor.
The SOM also focuses on dosages of medications being used with residents (including duplicate medication therapy):
- A prescriber orders medication(s) 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(s) and therapeutic goals being considered or used.
Factors influencing the appropriateness of any doses:
- These 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 SOM says the following about duplicate therapy:
- 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.
- Some examples of potentially problematic duplicate therapy include:
- Use of more than one product containing the same medication can lead to excessive doses of a medication, such as concomitant use of acetaminophen/hydrocodone and acetaminophen, which may increase the risk of acetaminophen toxicity;
- Use of multiple laxatives to improve or maintain bowel movements, which may lead to abdominal pain or diarrhea;
- Concomitant use of multiple benzodiazepines such as lorazepam for anxiety and temazepam for sleep, which may increase fall risk; or
- Use of medications from different therapeutic categories that have similar effects or properties, such as multiple medications with anticholinergic effects (e.g., oxybutynin and diphenhydramine), which may increase the risk of delirium or excessive sedation.
Documentation is necessary to clarify the rationale for and benefits of duplicate therapy and the approach to monitoring for benefits and adverse consequences. This documentation may be found in various areas of the resident’s clinical record.
Duration of medication therapy also is a focus of the SOM:
- 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(s) may have been demonstrated in the clinical record, or the staff and prescriber may present pertinent clinical reasons for the duration of use.
- Common considerations for appropriate duration may include:
- A medication initiated as a result of a time-limited condition (for example, delirium, pain, infection, nausea and vomiting, cold and cough symptoms, or itching) is then discontinued when the condition has resolved, or there is documentation indicating why continued use is still relevant. Failure to review whether the underlying cause has resolved may lead to excessive duration.
- A medication is discontinued when indicated by facility stop order policy or by the prescriber’s order, unless there is documentation of the clinical justification for its extended use. A medication administered beyond the stop date established in the prescriber’s order or by facility policy, without evidence of clinical justification for continued use of the medication, may be considered excessive duration.
The SOM also focuses on the expectation that, where appropriate, facilities will attempt to taper medication dosage and gradual dose reduction (GDR):
- 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. The purpose of tapering a medication is to find an optimal dose or to determine whether continued use of the medication is benefiting the resident. 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.
- Facility staff assigned to monitor medication management may wish to consider the following steps to include in their medication management compliance process:
- Opportunities during the care process to evaluate the effects of medications on a resident’s function and behavior and to consider whether the medication should be continued, reduced, discontinued or otherwise modified can include the following;
- During the monthly medication regimen review, the pharmacist evaluates resident-related information for dose, duration, continued need, and the emergence of adverse consequences for all medications;
- When evaluating the resident’s progress, the practitioner reviews the total plan of care, orders, the resident’s response to the medication(s), and determines whether to continue, modify, or stop a medication; and
- During the quarterly MDS review, the facility evaluates mood, function, behavior, and other domains that may be affected by medications.
The SOM has the following guidance on monitoring adverse consequences of medication therapy:
- Any medication or combination of medications can cause adverse consequences. Adverse consequences may become evident at any time after the medication is initiated. 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 always preventable, many ADRs can be anticipated, minimized, or prevented.
Some adverse consequences may be avoided by:
- Following relevant clinical guidelines and manufacturer’s specifications for use, dose, administration, duration, and monitoring of the medication;
- Defining appropriate indications for use; and
- Determining that the resident:
- Has no known allergies to the medication;
- Is not taking other medications, nutritional supplements or foods that would be incompatible with the prescribed medications; and
- Has no condition, history, or sensitivities that would preclude use of that medication.
CMS has focused in recent years heavily on pain medications and certain other specific types of medications:
- Commonly used medications are those to reduce pain or to thin the blood. With respect to each, note the following:
- With respect to pain medication, the CMS and the state survey agencies have made this an extremely high priority. Frequently, physician orders for pain medications are “PRN” (as needed). When charted that way, it can be confusing to the caregivers. You may wish to consider requesting physicians to order these types of medications for “routine” administration so they are more likely to be given on a regular schedule even if it is for a limited period of time to take care of the interim problem.
- Blood thinners such as Coumadin can have serious side effects and because they are used so frequently in nursing facilities staff should be educated and reeducated on some of these side effects and the need to have the resident’s physician check the time it takes for the blood to start the clotting process (post-trothrombin time).
In monitoring your facility’s compliance with the expectations of CMS and the OIG regarding medication management, your compliance staff/team should consider including the following inquiries:
- Do you have a medication administration system in place?
- Is it an accountable system?
- Is it tested and evaluated?