CMS' bitter pill: facilities must swallow new F-Tag guidance on unnecessary drugs and pharmacy services.

Nursing homes will need more than a spoonful of sugar to make CMS' new F-Tags on medication management palatable. Drastic changes will require facilities to closely review residents' medication regimens--and keep impeccable documentation to prove that they have done so. After providing almost two years for public comment, CMS recently updated the pharmacy and medication regulatory F-tags #329, #425, #428, and #431, which become effective December 15. Comprising more than 100 pages of new and revised language, the unnecessary drugs and pharmacy services tags will require significantly increased participation on the parts of the pharmacist, the facility staff, and the resident and/or responsible party. Even skilled nursing facilities used to CMS' frequent regulatory changes will find complying with these new guidelines a challenging task.

Overview: Unnecessary medications

The basic essentials governing unnecessary drugs are still applicable--the regulation has merely been refined and updated. An "unnecessary drug" is any drug when used (i) in excessive dose (including duplicate therapy), (ii) for excessive duration, (iii) without adequate monitoring, (iv) without adequate indications for its use, or (v) in the presence of adverse consequences that indicate the dose should be reduced or discontinued.

The emphasis of the regulations is on the decision-making process and interventions affecting drug regimen, as well as a resident's quality of life. The first step to take to avoid unnecessary drugs is training nurses to ask physicians when medications are ordered to clarify the indication and any unusual doses if the physician has not done so. A telephone order form could even contain a line for indication.

Pharmacists should seek clarification from facility nurses for unusual medications or dosages. Nurses will either fax or phone new orders to the pharmacy, so the pharmacist needs to be aware that he or she should intervene regardless of how he or she obtained information related to new orders The nurse will in turn contact the physician for clarification.

Under the new guidelines, facilities must conduct monthly medication reviews consisting of assessments of unnecessary drugs and excessive doses. You must implement a system that incorporates monitoring for drug effectiveness (see "The drugs aren't working!" on p. 18).

The big picture

The intent of the updates is to make sure that each resident's medication regimen helps him or her achieve or maintain an optimal level of well-being physically, mentally, and psychosocially. The other facet of the regulation is to ensure proper receiving, storage, handling, and distribution of medications.

The resident/responsible party will become members of the team responsible for collaboration regarding an optimal medication regimen. The updated regulations are clear that nursing homes must establish policies that coincide with the regulations.

Antipsychotics and unnecessary meds

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.

Compliance with this regulation will require effort on the part of the physician, the pharmacist, and the staff. Train the interdisciplinary team in identification and implementation of behavioral interventions.

Key changes also include the unnecessary drug mandate for resident/family involvement in the decision-making process regarding medications, an increased emphasis on the need for behavioral versus drug intervention when possible, increased emphasis on a team approach, and staff accountability for drug monitoring.

Get residents involved

There is a new emphasis on resident involvement in the medication regimen under F-Tag #329. A key component of the change is the need for collaboration with the resident and/or representative and the attending physician or staff.

Surveyors have been instructed to interview resident/family members to determine whether the resident was involved in care planning, decision-making, and discussing goals related to the use of medications.

It is impossible to determine whether the resident met goals without evaluation; therefore, it will be necessary to establish a system for discussing medications with alert residents, establish goals relating to the therapeutic effectiveness of the medication, and evaluate that effectiveness.

There is no one-size-fits-all solution, but you will need to review current systems. Monitoring for changes in resident condition will be essential. This will require systems for communicating changes, staff training, and monitoring.

Certified nursing assistants need to be an integral component of the system. They will need to know that if they see something different, they should report it. Impress upon your charge nurses the importance of documenting and following up on both subtle and obvious changes.

In addition, a perfect time for staff to perform a complete nursing assessment is in conjunction with the Minimum Data Set (MDS). Some facilities only complete risk assessments, instead of a comprehensive, holistic nursing assessment.

In-depth staff training on established systems and expectations is essential. Nurses must take the time to truly assess residents for changes in condition. For instance, a resident may have edema, and when nurses are questioned, they respond, "He has always had that." Yet when the surveyor reviews the chart, it makes no mention of the edema.

Pharmaceutical services

The goal of F-Tags #425, #428, #431 is to ensure that pharmacy services are an integral component of care delivery. Often, charge nurses spend more time on the delivery of medication than any other task.

Timeliness is a requirement for medication provision. Timeliness is governed by the situation, the resident's health status, and the type of medication. The regulations address the timeliness of delivery for new and existing residents.

You will need to have several processes in place to ensure timely delivery of nonroutine medication. The first line of defense is to have an emergency box that is stocked with both emergency medications and routine antibiotics. Consider maintaining at least a three-day supply. This will help with emergencies, as well as when the physician orders a medication on a Friday before a long weekend.

Drug regimen review

The required monthly drug regimen review is used to thoroughly evaluate each resident's medication regime. The goal of the evaluation is to promote positive outcomes and minimize adverse consequences related to the use of medication.

Identification of irregularities and adverse consequences resulting from or associated with medications for each resident by the pharmacist must be reported to the director of nursing and attending physician. Staff must show evidence of action in the documentation.

According to CMS, the review includes preventing, identifying, reporting, and resolving medication-related problems, medication errors, or other irregularities, and collaborating with the other members of the interdisciplinary team.

One facet of the new tags is the emphasis on a more detailed review, taking into consideration the impact of factors such as meal times on the medication.

Some medications should be taken with food, whereas others must be taken on an empty stomach. There are some foods that need to be avoided when taking certain medications. MAO inhibitors, for example, react with certain foods and medications.

The review process

The pharmacist must evaluate any irregularity that affects pharmaceutical services as it relates to resident, medical care, or facility processes. This review must include both the medication system from delivery through discharge and clinical factors such as unnecessary medications or medications without indications for use.

Documents useful to the review include medication administration records (MAR); physician's orders; progress, nursing, and consultants' notes; the MDS; laboratory and diagnostic test results; behavioral monitoring information; and the progress notes of the dietary, social service, and activities departments. The pharmacist should also consider gathering data by interviewing the resident, physician, and facility staff.

According to the new revisions, the drug regimen review should consider the following:

* Indications for use of the medication are appropriately documented

* The benefits outweigh the risks involved with the use of the specific medication

* Potential interactions within the regimen and the residents diet

* A resident's response to the medications being monitored

* Action taken in response to evidence of medication toxicity, adverse drug reactions, or lack of progress toward the therapeutic goals for the medication

* Consistency of the medication dose, frequency, route of administration, and duration with the resident's condition, manufacturer's recommendations, and applicable standards of practice

* Changes in the resident's condition that could be the result of one or more of the medications the resident is receiving

There are several methods of achieving compliance with this regulation. One method is to make sure the pharmacist works with the care team on a regular basis. The care team must ensure that each medication's purpose, dose, time, duration, and route is listed in the MAR. For example, the MAR may list "Milk of Magnesia" 30 cc QOD PO HS for chronic constipation. The review should consider whether the resident was assessed and whether nondrug interventions such as fluid, fiber, and exercise were attempted.

Go team!

The drug regimen review is now expected to be conducted by the entire care team.

The physician is expected to review the regimen during each visit, and the nurse must review medications when sending orders to the pharmacy and/or prior to administering medications. The interdisciplinary team will review it within the resident assessment instrument processes, and the pharmacist will review it prior to filling a prescription as well as monthly with the drug regimen review.

Although a change in condition may or may not be related to medication use, any negative change should be reviewed for a possible relationship with the medication regimen. Examples of specific changes are listed in the regulation. If a change is related to medication use and there is some benefit in addition to a possible adverse consequence, then the risks and benefits must be weighed.

Dose, duration, indications for use, monitoring, gradual dose reduction for antipsychotics, and adverse consequences must be considered by the pharmacist as well as the interdisciplinary care team.

The drugs aren't working!

CMS' new guidance requires nursing homes to monitor the effectiveness of medications. Nursing homes can accomplish this through documentation systems. Documentation of drug effectiveness could involve several different systems.

For example, the nurse can record the effectiveness of a pain medication directly on the medication administration record. The staff could place a number from 1-10 under the nurse's initials or use I (ineffective) and E (effective). The one-to-ten pain scale is a more refined method of documenting the effectiveness of pain medication.

A method for determining the effectiveness of a laxative could include a review of a bowel movement flowsheet or the medication administration record.

Discontinuation of medications

When a resident requires treatment of symptoms/an acute condition, nursing staff should give special attention to discontinuing those medications when the resident no longer needs the drug.

If the medication is continued, there should be clinical documentation supporting the continuation of the medication, and the resident/representative must be included in the discussion regarding options. Even when there is an acute situation, behavioral approaches should be considered.

Because there are social, behavioral, and nutritional components to medication regime's, this is a perfect opportunity to discuss continued need for medications, side effects, adverse reactions, and behavioral interventions.

Labeling and storage

Drugs must be labeled in accordance with currently accepted professional principles and include the appropriate accessory and cautionary instructions and the expiration date when applicable. This means that your facility should have routine systems to check medication refrigerators, medication carts, and emergency boxes. The facility may also decide to utilize the quality assurance process to monitor for ongoing compliance.

Medications must be stored in locked compartments at the proper temperature. Only authorized individuals should have keys. The intent is to keep residents and staff from diverting medications.

A common mistake facilities make is allowing housekeepers to go into medication rooms to mop. Arrangements need to be made to supervise this process. Nurses must also secure the medication when delivering drugs. Therefore, they should not leave medications on a cart and walk into a resident's room to deliver medications. If residents self-administer medications, the facility must follow the same storage guidelines.

A new key emphasis of the storage requirement is requiring the facility to follow the manufacturer's directions for storage. Your staff must work closely with the pharmacy to determine proper storage.

Medications must be labeled in accordance with federal and state labeling requirements and accepted standards of practice. This means that each medication should be labeled by the pharmacy and include the resident's name, the route, the strength of the medication, the expiration date, and, when applicable, accessory and cautionary instructions.

NOTE: Controlled medications--The facility must provide separately locked, permanently affixed compartments for storage of controlled substances listed in schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976, except when a facility uses single-unit packages, the quantity stored is minimal, and a missing dose can be readily detected.

--Janie Krechting

Six degrees of compliance

Six specific aspects of the unnecessary medications requirement require that medication therapy is appropriate for the individual resident. Your facility must ensure that medication therapy (including administration of antipsychotic agents) is based upon the following:

1. An adequate indication for use

2. Use of the appropriate dose

3. Provision of behavioral interventions and gradual dose reduction for individuals receiving antipsychotics (unless clinically contraindicated) in an effort to reduce or discontinue the medication

4. Use for the appropriate duration

5. Adequate monitoring to determine whether therapeutic goals are met and detect the emergence or presence of adverse consequences

6. Reduction of dose or discontinuation of the medication in the presence of adverse consequences, as indicated--Janie Krechting

Janie Krechting, BSN, RN, MGS, LNHA, has worked in various capacities in long-term care since 1971, when she started her first job washing dishes. She has been a certified nursing assistant, charge nurse, supervisor, assistant DON, and DON. She was an assistant professor in the Aging Services and Administration program at the College of Mount St Joseph in Cincinnati for 18 years, consulted in various nursing homes, and is the author of numerous books. Contact her at [e-mail].